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A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01358877
Recruitment Status : Active, not recruiting
First Posted : May 24, 2011
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Genentech, Inc.
Breast International Group
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: 5-Fluorouracil Drug: Carboplatin Drug: Cyclophosphamide Drug: Docetaxel Drug: Doxorubicin Drug: Epirubicin Drug: Paclitaxel Drug: Pertuzumab Drug: Placebo Drug: Trastuzumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Actual Study Start Date : November 8, 2011
Primary Completion Date : December 19, 2016
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pertuzumab + Trastuzumab + Chemotherapy
Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
Drug: 5-Fluorouracil
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
Drug: Carboplatin
Carboplatin will be administered as per the schedule specified in the respective arm.
Drug: Cyclophosphamide
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Drug: Docetaxel
Docetaxel will be administered as per the schedule specified in the respective arm.
Drug: Doxorubicin
Doxorubicin will be administered as per the schedule specified in the respective arm.
Drug: Epirubicin
Epirubicin will be administered as per the schedule specified in the respective arm.
Drug: Paclitaxel
Paclitaxel will be administered as per the schedule specified in the respective arm.
Drug: Pertuzumab
Pertuzumab will be administered as per the schedule specified in the respective arm.
Other Name: Perjeta®
Drug: Trastuzumab
Trastuzumab will be administered as per the schedule specified in the respective arm.
Other Name: Herceptin®
Placebo Comparator: Placebo + Trastuzumab + Chemotherapy
Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]).
Drug: 5-Fluorouracil
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
Drug: Carboplatin
Carboplatin will be administered as per the schedule specified in the respective arm.
Drug: Cyclophosphamide
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Drug: Docetaxel
Docetaxel will be administered as per the schedule specified in the respective arm.
Drug: Doxorubicin
Doxorubicin will be administered as per the schedule specified in the respective arm.
Drug: Epirubicin
Epirubicin will be administered as per the schedule specified in the respective arm.
Drug: Paclitaxel
Paclitaxel will be administered as per the schedule specified in the respective arm.
Drug: Placebo
Placebo will be administered as per the schedule specified in the respective arm.
Drug: Trastuzumab
Trastuzumab will be administered as per the schedule specified in the respective arm.
Other Name: Herceptin®



Primary Outcome Measures :
  1. Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months) ]
    Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.

  2. Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: 3 years ]
    Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.


Secondary Outcome Measures :
  1. Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months) ]
    Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).

  2. Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: 3 years ]
    Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).

  3. Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months) ]
    Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.

  4. Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: 3 years ]
    Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.

  5. Percentage of Participants Who Died [ Time Frame: Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months) ]
    Percentage of participants who died due to any cause is reported.

  6. Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3 [ Time Frame: 3 years ]
    The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years.

  7. Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months) ]
    Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.

  8. Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: 3 years ]
    Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence.

  9. Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months) ]
    Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.

  10. Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: 3 years ]
    Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence.

  11. Percentage of Participants With Primary Cardiac Event [ Time Frame: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months) ]
    Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.

  12. Percentage of Participants With Secondary Cardiac Event [ Time Frame: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months) ]
    Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).

  13. Change From Baseline in LVEF to Worst Post-Baseline Value [ Time Frame: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months) ]
    LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.

  14. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score [ Time Frame: Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36 ]
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.

  15. Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.

  16. Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.

  17. Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.

  18. Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.

  19. Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.

  20. Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.

  21. Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.

  22. Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.

  23. Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.

  24. Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain [ Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 ]
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.

  25. Trough Serum Concentration (Cmin) of Pertuzumab [ Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days) ]
  26. Cmin of Trastuzumab [ Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days) ]
  27. Peak Serum Concentration (Cmax) of Pertuzumab [ Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days) ]
  28. Cmax of Trastuzumab [ Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
  • Known hormone receptor status (estrogen receptor and progesterone receptor)
  • The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
  • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
  • Confirmed HER2 positive status
  • Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
  • Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug

Exclusion Criteria:

  • History of any prior (ipsi- and/or contralateral) invasive breast cancer
  • History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
  • Any node-negative tumor
  • Any previous systemic chemotherapy for cancer or radiotherapy for cancer
  • Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
  • Concurrent anti-cancer treatment in another investigational trial
  • Serious cardiac or cardiovascular disease or condition
  • Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
  • Abnormal laboratory tests immediately prior to randomization
  • Pregnant or lactating women
  • Sensitivity to any of the study medications or any of the ingredients or excipients of these medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358877


  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85025
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States, 85258
United States, Arkansas
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Providence Regional Medical Center
Everett, California, United States, 98208
Marin Cancer Care Inc
Greenbrae, California, United States, 94904
Kaiser Permanente - Hayward
Hayward, California, United States, 94545
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente - Oakland
Oakland, California, United States, 94611
Kaiser Permanente - Roseville
Roseville, California, United States, 95661
Sutter Cancer Center
Sacramento, California, United States, 95816
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States, 95825
Southern California Kaiser Permanente
San Diego, California, United States, 92108
K. Permanente - San Fransisco
San Francisco, California, United States, 94115
Pacific Hematology Oncology Assocociates
San Francisco, California, United States, 94115
K. Permanente - San Jose
San Jose, California, United States, 95119
K. Permanente - Santa Clara
Santa Clara, California, United States, 95051
K. Permanente - S. San Fran
South San Francisco, California, United States, 94080
Kaiser Permanente; Oncology Clinical Trials
Vallejo, California, United States, 94589
K. Permanente - Walnut Creek
Walnut Creek, California, United States, 94596
United States, Colorado
Rocky Mountain Cancer Center - Denver
Denver, Colorado, United States, 80220
Lutheran Hematology &Oncology
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Eastern Ct Hema/Onco Assoc; Dept of Oncology
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Washington Cancer Institute at MedStar Washington Hospital Center.
Washington, District of Columbia, United States, 20010
Georgetown U; Lombardi Comp Can
Washington, District of Columbia, United States, 20016-1468
United States, Florida
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States, 33901
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States, 32256
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33804-1057
Ocala Oncology Center
Ocala, Florida, United States, 34471
Memorial Breast Cancer Center
Pembroke Pines, Florida, United States, 33028-1006
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Florida Cancer Specialists; Saint Petersburg
Saint Petersburg, Florida, United States, 33719
Florida Cancer Specialists, Research Department
West Palm Beach, Florida, United States, 33401
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States, 30060
United States, Idaho
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Uni of Chicago
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Med Center
Maywood, Illinois, United States, 60153
Edward Cancer Center Naperville
Naperville, Illinois, United States, 60540
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Edward Cancer Center Plainfield
Plainfield, Illinois, United States, 60585
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, United States, 62301
Carle Foundation
Urbana, Illinois, United States, 61801
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Siouxland Hematology/Oncology
Sioux City, Iowa, United States, 51101
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Cancer Center of Acadiana at Lafayette General
Lafayette, Louisiana, United States, 70506
United States, Maine
Cancer Care of Maine
Brewer, Maine, United States, 04412
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Weinberg CA Inst Franklin Sq
Baltimore, Maryland, United States, 21237
Maryland Oncology & Hematology, PA
Bethesda, Maryland, United States, 20817
Associates in Oncology/Hematology, P.C.
Kensington, Maryland, United States, 20895
United States, Massachusetts
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Dana Farber Cancer Institute at Faulkner Hospital
Boston, Massachusetts, United States, 02130
Beth Israel Deac Med Ctr; East Campus Rsch Pharmacy
Boston, Massachusetts, United States, 02215
Dana Farber Can Ins
Boston, Massachusetts, United States, 02215
Berkshire Hematology, Oncology Pc
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
Southdale Cancer Clinic
Edina, Minnesota, United States, 55414
Mayo Clinic Rochester; Medical Oncology
Rochester, Minnesota, United States, 55905
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
United States, Missouri
University of Missouri-Columbi; Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Heartland CCOP/Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
United States, Montana
MT Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
Cancer Alliance of Nebraska
Lincoln, Nebraska, United States, 68510
Cancer Alliance of Nebraska
Omaha, Nebraska, United States, 68106
United States, New Hampshire
Dartmouth Hitchcock Med Center
Lebanon, New Hampshire, United States, 03756
Norris Cotton Cancer Center- Manchester
Manchester, New Hampshire, United States, 03102
United States, New Jersey
MSKCC at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Montefiore Medical Center
Bronx, New York, United States, 10467
Roswell Park Cancer Inst.
Buffalo, New York, United States, 14263
Memorial Sloan-Kettering; Cancer Center
Commack, New York, United States, 11725
Mount Sinai Beth Israel Medical Center
New York, New York, United States, 10003
Mount Sinai Beth Israel Comprehensive Cancer Center
New York, New York, United States, 10011
Mount Sinai West
New York, New York, United States, 10019
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering CC
Rockville Centre, New York, United States, 11570
MSKCC at Sleepy Hollow
Sleepy Hollow, New York, United States, 10591
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, United States, 28602
United States, North Dakota
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122-9988
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
Columbus, Ohio, United States, 43219
Dayton Clinical Oncology Prog
Dayton, Ohio, United States, 45420
Toledo Clinic Cancer Center-Oregon
Oregon, Ohio, United States, 43616
United States, Oregon
Northwest Cancer Specialists - Portland (NE Hoyt St)
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abramson Cancer Center; Univ of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Healthcare Network ; Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29414
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, United States, 29210
Cancer Centers of the Carolina; Eastside Medical Center
Greenville, South Carolina, United States, 29615
United States, South Dakota
Sanford USD School of Medicine
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States, 37404
Kingsport Hematology Oncology Associates
Kingsport, Tennessee, United States, 37660
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, United States, 37203
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204
United States, Texas
Texas Oncology-Medical City Dallas
Dallas, Texas, United States, 75230
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8813
Texas Oncology-El Paso Cancer Treatment Center Grandview
El Paso, Texas, United States, 79902
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, United States, 76104
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, United States, 76104
US Oncology Research Pharm.
Fort Worth, Texas, United States, 76177
Texas Oncology, P.A. - Garland
Garland, Texas, United States, 77060
Baylor College of Medicine
Hoston, Texas, United States, 77096
Texas Oncology - Houston (Gessner)
Houston, Texas, United States, 77024
Ben Taub General Hospital - HCHD
Houston, Texas, United States, 77030
Cancer Care Centers of South Texas-HOAST - San Antonio
New Braunfels, Texas, United States, 78130
Texas Oncology-Plano East
Plano, Texas, United States, 75075-7787
US Oncology
The Woodlands, Texas, United States, 77380
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Virginia
Wellmonth Physician Services
Bristol, Virginia, United States, 24201
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
United States, Washington
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
United States, West Virginia
West Virginia University Hospitals Inc
Morgantown, West Virginia, United States, 26056
United States, Wisconsin
Green Bay Oncology/St. Mary's Hospital
Green Bay, Wisconsin, United States, 54301
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54311
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Argentina
IMCABA
Buenos Aires, Argentina, 1185
CER Instituto Médico Oncología
Florencio Varela, Argentina, B1878DVB
Instituto de Oncología de Rosario
Rosario, Argentina, S2000KZE
Centro Medico San Roque
San Miguel de Tucuman, Argentina, T4000IAK
Isis Centro Especializado de Luces; Oncology
Santa Fe, Argentina, 03000
Australia, New South Wales
Lismore Base Hospital; Cancer Care & Haematology Unit
Lismore, New South Wales, Australia, 2480
Mater Misericordiae Hospital; Chemotherapy Cottage
Sydney, New South Wales, Australia, 2060
Newcastle Mater Misericordiae Hospital; Oncology
Waratah, New South Wales, Australia, 2298
Westmead Hospital; Medical Oncology and Pallative Care
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Wesley Medical Centre; Clinic For Haematology and Oncology
Auchenflower, Queensland, Australia, 4066
Mater Hospital; Oncology
Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital; Oncology
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Royal Hobart Hospital; Medical Oncology
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Monash Medical Centre; Oncology
Clayton, Victoria, Australia, 3168
Geelong Hospital; Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3220
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia, 3084
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Sir Charles Gairdner Hospital; Medical Oncology
Perth, Western Australia, Australia, 6009
Austria
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
Graz, Austria, 8036
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Innsbruck, Austria, 6020
Kh Der Barmherzigen Schwestern; Interne I X
Linz, Austria, 4010
Lhk Feldkirch; Interne Medizin Abt.
Rankweil, Austria, 6830
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
A. Ö. Krankenhaus Der Barmherzigen Brüder; Interne Abt.
St Veit An Der Glan, Austria, 9300
Lkh Vöcklabruck; I. Abt. Für Innere Medizin
Vöcklabruck, Austria, 4840
Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
Wels, Austria, 4600
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Wien, Austria, 1090
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Wien, Austria, 1090
Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe
Wien, Austria, 1130
Belgium
Institut Jules Bordet
Bruxelles, Belgium, 1000
GHdC Site Notre Dame
Charleroi, Belgium, 6000
UZ Antwerpen
Edegem, Belgium, 2650
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium, 3500
AZ Groeninge (Loofstraat)
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
CHU Sart-Tilman
Liège, Belgium, 4000
Clinique Ste-Elisabeth
Namur, Belgium, 5000
Sint Augustinus Wilrijk
Wilrijk, Belgium, 2610
Bulgaria
UMHAT Tsaritsa Yoanna - ISUL; Clinic of Oncotherapy
Sofia, Bulgaria, 1527
SHATO - Sofia
Sofia, Bulgaria, 1756
SHATOD Dr. Marko Antonov Markov-Varna, EOOD
Varna, Bulgaria, 9010
Canada, Alberta
Tom Baker Cancer Centre; Dept of Medicine
Calgary, Alberta, Canada, T2N 4N2
Cross Can Inst
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency, CSI
Kelowna, British Columbia, Canada, V1Y 5L3
Bcca-Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Bcca - Vancouver Island Cancer Centre; Oncology
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba; Neuro-Oncology
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Atlantic Health Science Corporation; Saint John Regional Hospital Facility
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario; Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, Canada, L5M 2N1
Southlake Regional Health Center
Newmarket, Ontario, Canada, L3Y 2R2
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site
St. Catharines, Ontario, Canada, L2R 7C6
Northeastern Ontario; Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1Z5
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, Canada, H1T 2M4
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec, Canada, H2L 4M1
Hopital Sacre-Coeur Research Centre
Montreal, Quebec, Canada, H4J 1C5
Hopital du Saint Sacrement
Quebec City, Quebec, Canada, G1S 4L8
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Chile
Fundacion Arturo Lopez Perez
Santiago, Chile, 7500921
INTOP
Santiago, Chile, 7501088
Centro de Investigaciones Clínicas (CENIC)
Santiago, Chile, 7501239
Instituto Nacional del Cancer
Santiago, Chile, 8380000
China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China, 100021
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, China, 100071
Jilin Cancer Hospital
Changchun, China, 130012
the First Hospital of Jilin University
Changchun, China, 130021
Hu Nan Provincial Cancer Hospital
Changsha, China, 410006
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Fujian Medical University Union Hospital
Fujian, China, 350001
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, China, 110016
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Guangdong General Hospital
Guangzhou, China, 510080
The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
Hangzhou, China, 310003
Harbin Medical University Cancer Hospital
Harbin, China, 150081
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, China, 330006
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Shanghai First People's Hospital
Shanghai, China, 200080
Changhai Hospital of Shanghai
Shanghai, China, 200433
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, China, 050035
First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, China, 430022
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, China, 430030
Hubei Cancer Hospital
Wuhan, China, 430079
Colombia
Fundacion Cardioinfantil
Bogota, Colombia
Inst. Nacional de Cancerologia; Clinica de Seno
Bogota, Colombia
Hospital Pablo Tobon Uribe
Medellin-Antioquia, Colombia
Oncomedica S.A.
Monteria, Colombia, 230002
Croatia
Uni Hospital Split; Oncology & Radiotherapy
Split, Croatia, 21000
General Hospital Varazdin
Varazdin, Croatia, 42000
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Czechia
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
Pardubice, Czechia, 532 03
Denmark
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg, Denmark, 9000
Sydvestjysk Sygehus Esbjerg; Onkologisk afdeling
Esbjerg, Denmark, 6700
Herlev Hospital; Onkologisk afdeling
Herlev, Denmark, 2730
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerod, Denmark, 3400
Rigshospitalet, Onkologisk Klinik
København Ø, Denmark, 2100
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
Naestved, Denmark, 4700
Odense Universitetshospital, Onkologisk Afdeling R
Odense, Denmark, 5000
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
Roskilde, Denmark, 4000
Vejle Sygehus Onkologisk Afd
Vejle, Denmark, 7100
El Salvador
Hospital Oncologia; Oncology
Salvador, El Salvador, 01101
Hospital Diagnostico Escalón
San Salvador, El Salvador, 01101
France
Clinique De L Europe; Pmsi
Amiens, France, 80090
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, France, 62012
Institut Sainte Catherine
Avignon, France, 84918
Institut Bergonie; Oncologie
Bordeaux, France, 33076
Polyclinique Bordeaux Nord
Bordeaux, France, 33300
Hopital Augustin Morvan; Federation De Cancerologie
Brest, France, 29200
Centre Francois Baclesse; Recherche Clinique
Caen, France, 14076
Centre Jean Perrin; Hopital De Jour
Clermont Ferrand, France, 63011
Centre Leonard De Vinci;Chimiotherapie
Dechy, France, 59187
Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
Dijon, France, 21034
Institut Daniel Hollard
Grenoble, France, 38000
Centre Hospitalier Departemental Les Oudairies
La Roche Sur Yon, France, 85925
Clinique des Ormeaux; Oncologie
Le Havre, France, 76600
Centre Oscar Lambret; Cancerologie Gynecologique
Lille, France, 59020
Hopital Dupuytren; Oncologie Medicale
Limoges, France, 87042
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Institut Paoli Calmettes; Oncologie Medicale
Marseille, France, 13273
Institut régional du Cancer Montpellier
Montpellier, France, 34298
Polyclinique De Gentilly; Hemodialyse
Nancy, France, 54100
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, France, 06189
Polyclinique Kenval ; Radiotherapie Oncologie
Nimes, France, 30900
Institut Curie; Oncologie Medicale
Paris, France, 75231
Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
Paris, France, 75651
Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
Perigueux, France, 24000
Clinique Armoricaine Radiologie; Hopital de Jour
Plerin, France, 22190
Chu De Poitiers; Chu La Miletrie
Poitiers, France, 86021
Institut Jean Godinot; Hopital De Jour
Reims, France, 51056
Polyclinique De Courlancy; Centre Radiotherapie Oncologie
Reims, France, 51057
Centre Eugene Marquis; Unite Huguenin
Rennes, France, 35042
Centre Henri Becquerel; Oncologie Medicale
Rouen, France, 76038
Ico Rene Gauducheau; Oncologie
Saint Herblain, France, 44805
ICL; Hematologie
Saint-Priest en Jarez, France, 42271
Centre Rene Huguenin; CONSULT SPECIALISEES
St Cloud, France, 92210
Clinique Chir De L Orangerie; Chimiotherapie
Strasbourg, France, 67010
Hopital Hautepierre; Hematologie Oncologie
Strasbourg, France, 67098
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Clinique Pasteur; Pneumologie
Toulouse, France, 31076
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre Les Nancy, France, 54511
Institut Gustave Roussy; Oncologie Medicale
Villejuif, France, 94800
Germany
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
Amberg, Germany, 92224
Ambulantes Onkologie Centrum Dres. Hahn/Müller
Ansbach, Germany, 91522
Hochwaldkrankenhaus
Bad Nauheim, Germany, 61231
Evang. Krankenhaus Frauenklinik
Bergisch Gladbach, Germany, 51465
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
Berlin, Germany, 10367
Praxis Dr. Schoenegg
Berlin, Germany, 10719
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
Berlin, Germany, 13125
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
Berlin, Germany, 14169
Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
Bielefeld, Germany, 33604
Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde
Bonn, Germany, 53127
Praxis Dr. Ralf Lorenz
Braunschweig, Germany, 38100
Internistische Praxis Dr. Döring (Im St. Joseph Stift)
Bremen, Germany, 28209
Klinikum Sindelfingen-Böblingen; Frauenklinik
Böblingen, Germany, 71032
Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik
Chemnitz, Germany, 09116
DONAU ISAR Klinikum Deggendorf; Frauenklinik
Deggendorf, Germany, 94469
St. Johannes Hospital
Dortmund, Germany, 44137
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf; Frauenklinik
Düsseldorf, Germany, 40225
Luisenkrankenhaus GmbH, Brustzentrum
Düsseldorf, Germany, 40235
Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze
Erfurt, Germany, 99085
Universitätsklinikum Erlangen; Frauenklinik
Erlangen, Germany, 91054
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
Esslingen, Germany, 73730
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt am Main, Germany, 60389
Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
Frankfurt, Germany, 60596
Städtische Kliniken Frankfurt am Main Höchst
Frankfurt, Germany, 65929
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg, Germany, 79110
Dres.Jochen Wilke und Harald Wagner
Fürth, Germany, 90766
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
Greifswald, Germany, 17475
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
Halle, Germany, 06120
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Hamburg, Germany, 20246
SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum
Hameln, Germany, 31785
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
Hannover, Germany, 30177
Diakovere Henriettenstift, Frauenklinik
Hannover, Germany, 30559
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, Germany, 69120
Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
Hildesheim, Germany, 31134
Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
Homburg/Saar, Germany, 66424
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
Karlsruhe, Germany, 76135
Elisabeth-Krankenhaus Brustzentrum
Kassel, Germany, 34117
Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
Kassel, Germany, 34125
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
Kiel, Germany, 24105
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Koeln, Germany, 50935
Klinik und Poliklinik; Brustzentrum
Köln, Germany, 50931
Klinikum Landshut Frauenklinik
Landshut, Germany, 84034
Sankt Elisabeth Krankenhaus; Gynaekology
Leipzig, Germany, 04277
Evangelisches Krankenhaus; Abt. Gynäkologie und Geburtshilfe
Ludwigsfelde, Germany, 14974
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, Germany, 23538
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, Germany, 55131
Rotkreuzklinikum München; Frauenklinik
Muenchen, Germany, 80637
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach, Germany, 41061
Klinikum der Universität München; Frauenklinik - Onkologie II
München, Germany, 80337
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
München, Germany, 81675
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, Germany, 48149
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, Germany, 63069
Klinikum Oldenburg AöR; Universitätsklinik für Innere Medizin - Onkologie und Hämatologie
Oldenburg, Germany, 26133
Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum
Ravensburg, Germany, 88212
Praxis für Onkologie und Hämatologie
Recklinghausen, Germany, 45657
RoMed Klinikum Rosenheim; Klinik für Gynäkologie und Geburtshilfe
Rosenheim, Germany, 83022
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
Rostock, Germany, 18059
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
Stade, Germany, 21680
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, Germany, 54290
Universitätsklinik Tübingen; Frauenklinik
Tübingen, Germany, 72076
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
Ulm, Germany, 89075
Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer
Velbert, Germany, 42551
Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe
Villingen-Schwenningen, Germany, 78052
St. Josefs-Hospital Wiesbaden GmbH; Klinik für Frauenheilkunde und Geburtshilfe
Wiesbaden, Germany, 65189
Marien-Hospital Witten; Frauenklinik Brustzentrum
Witten, Germany, 58452
Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker
Würzburg, Germany, 97080
Guatemala
Grupo Angeles
Guatemala City, Guatemala, 01015
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala, Guatemala, 01010
Hong Kong
Queen Mary Hospital; Surgery
Hong Kong, Hong Kong, 852
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Hungary
Semmelweis Egyetem Onkologiai Központ
Budapest, Hungary, 1083
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, Hungary, 1122
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary, H-1134
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen, Hungary, 4032
Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
Gyor, Hungary, 9024
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, Hungary, 5703
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
Kecskemet, Hungary, 6000
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, Hungary, 6720
Veszprem Megyei Csolnoky; Ferenc Korhaz
Veszprem, Hungary, 8200
Ireland
Cork Uni Hospital; Oncology Dept
Cork, Ireland
St Vincent'S Uni Hospital; Medical Oncology
Dublin, Ireland, 4
Mater Misericordiae Uni Hospital; Oncology
Dublin, Ireland, 7
St. James Hospital; Oncology
Dublin, Ireland, 8
Beaumont Hospital; Cancer Clinical Trials Unit
Dublin, Ireland, 9
Galway University Hospital; Clinical Trials Department
Galway, Ireland
University Hospital Limerick - Oncology
Limerick, Ireland
Israel
Rambam Medical Center; Oncology
Haifa, Israel, 3525408
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 9112001
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva, Israel, 4941492
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 5262100
Kaplan Medical Center; Oncology Inst.
Rehovot, Israel, 7610001
Sourasky / Ichilov Hospital; Oncology Department
Tel Aviv, Israel, 64239-06
Italy
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, Italy, 88100
AORN'S.G.Moscati; Oncologia
Avellino, Campania, Italy, 83100
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
Napoli, Campania, Italy, 80131
Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna
Napoli, Campania, Italy, 80131
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
Ospedale Ramazzini
Carpi, Emilia-Romagna, Italy, 41012
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, Italy, 42100
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli-Venezia Giulia, Italy, 33081
Divisione Onc Med dell'Azienda
Udine, Friuli-Venezia Giulia, Italy, 33100
Ospedale Belcolle Di Viterbo; Oncologia
Viterbo, Lazio, Italy, 01100
Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
Genova, Liguria, Italy, 16128
Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
Genova, Liguria, Italy, 16132
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova, Liguria, Italy, 16132
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
Brescia, Lombardia, Italy, 25123
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
Cremona, Lombardia, Italy, 26100
ASST DI LECCO; Oncologia Medica
Lecco, Lombardia, Italy, 23900
Ospedale Mater Salutis; Dept of Oncology
Legnago, Lombardia, Italy, 37045
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
Milano, Lombardia, Italy, 20141
Policlinico di Monza; Istituto di Oncologia
Monza, Lombardia, Italy, 20052
IRCCS Fondazione Maugeri; Oncologia Medica I
Pavia, Lombardia, Italy, 27100
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano, Lombardia, Italy, 20089
Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica
Saronno, Lombardia, Italy, 21047
Ospedale S. Croce Di Fano; Servizio Oncologia
Fano, Marche, Italy, 61032
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piemonte, Italy, 10060
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Puglia, Italy, 72100
Ospedale della Misericordia e Dolce; Radiologia
Prato, Toscana, Italy, 59100
Ospedale Di Bolzano; Dept. Di Oncologia
Bolzano, Trentino-Alto Adige, Italy, 39100
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Perugia, Umbria, Italy, 06156
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, Umbria, Italy, 05100
Japan
Aichi Cancer Center Hospital, Breast Oncology
Aichi, Japan, 464-8681
Chiba Cancer Center; Breast Surgical Oncology
Chiba, Japan, 260-8717
National Cancer Center Hospital East; Breast and Medical Oncology
Chiba, Japan, 277-8577
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center;Breast Oncology
Fukuoka, Japan, 811-1395
Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery
Gunma, Japan, 371-8511
Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
Hiroshima, Japan, 730-8518
Iwate Med Univ School of Med; Surgery
Iwate, Japan, 020-8505
Sagara Hospital; Breast Surgery
Kagoshima, Japan, 892-0833
St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
Kanagawa, Japan, 216-8511
Tokai University Hospital, Breast and Endocrine Surgery
Kanagawa, Japan, 259-1193
Kumamoto City Hospital, Breast and Endocrine Surgery
Kumamoto, Japan, 862-8505
Kumamoto Shinto General Hospital; Breast Cancer Center
Kumamoto, Japan, 862-8655
Kyoto University Hospital; Breast Surgery
Kyoto, Japan, 606-8507
Niigata Cancer Ctr Hospital; Breast Surgery
Niigata, Japan, 951-8566
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka, Japan, 540-0006
Osaka International Cancer Institute; Breast and Endocrine Surgery
Osaka, Japan, 541-8567
Saitama Medical University International Medical Center; Breast Oncology
Saitama, Japan, 350-1298
Saitama Cancer Center, Breast Oncology
Saitama, Japan, 362-0806
Shizuoka Cancer Center; Female Internal Medicine
Shizuoka, Japan, 411-8777
Shizuoka General Hospital; Breast Surgery
Shizuoka, Japan, 420-8527
Jichi Medical School ; Surgery
Tochigi, Japan, 329-0498
National Cancer Center Hospital; Breast and Medical Oncology
Tokyo, Japan, 104-0045
Tokyo Metropolitan; Komagome Hospital, Surgery
Tokyo, Japan, 113-8677
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo, Japan, 135-8550
Tokyo Medical Uni. Hospital; Breast Oncology
Tokyo, Japan, 160-0023
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, Korea, Republic of, 03080
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
Kyunghee University Hospital; Endocrinology
Seoul, Korea, Republic of, 130-702
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, Korea, Republic of, 135-710
Korea University Anam Hospital; Oncology Haemotology
Seoul, Korea, Republic of, 136-705
Mexico
Centro de Investigacion; Clinica Del Pacifico
Acapulco, Mexico, 39670
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
Centro Estatal de Oncología de Campeche
Campeche, Mexico, 24096
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Chihuahua, Mexico, 31000
Centro Estatal De Cancerologia De Durango; Oncology
Durango, Mexico, 34000
Núcleo de Especialidades Oncológicas
Guadalajara, Mexico, 44670
Fundacion Rodolfo Padilla Padilla A.C.
León, Mexico, 37000
Hospital Angeles Metropolitano; Room 220
Mexico City, Mexico, 06760
Hospital General de México; Unidad de Oncologia
Mexico DF, Mexico, 06726
Centro Universitario Contra El Cancer
Monterrey, Mexico, 64020
Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey
Monterrey, Mexico, 64710
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Hospital Privado San Jose; Oncologia
Obregon, Mexico, 85000
Cancerologia de Queretaro; Oncologia
Queretaro, Queretaro, Mexico, 76090
Centro Regional de Enfermedades Oncológicas, S.A.
San Luis Potosi, Mexico, 78218
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
Amphia ziekenhuis, locatie langendijk
Breda, Netherlands, 4819 EV
Reinier De Graaf Groep
Delft, Netherlands, 2625 AD
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, Netherlands, 6229 HX
Isala Klinieken
Zwolle, Netherlands, 8011 JW
New Zealand
Waikato Hospital; Dept of Medical Oncology
Hamilton, New Zealand, 3240
Palmerston North Hospital; Regional Cancer Treatment Service
Palmerston North, New Zealand, 4442
Panama
Centro Hemato Oncologico Paitilla
Panama City, Panama, 083200752
Centro Oncologico America
Panama, Panama, 0834-02723
Peru
Hospital Nacional Arzobispo Loayza; Oncology
Lima, Peru, 1
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
Lima, Peru, L27
Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología
Lima, Peru, Lima 1
Clinica El Golf
San Isidro, Peru, L27 Lima
Clinica Peruana Americana
Trujillo, Peru, 13011
Philippines
University Of Santo Tomas; Oncology; Benavides Cancer Institute
Manila, Philippines, 1008
Rizal Medical Center
Pasig City, Philippines, 1605
Veterans Memorial Medical Ctr; Cancer Research Centre
Quezon City, Philippines, 1101
Poland
Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
Bialystok, Poland, 15-027
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, Poland, 85-796
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdańsk, Poland, 80-952
Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
Opole, Poland, 45-060
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
Warszawa, Poland, 02-781
NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Skłodowskiej-Curie
Wieliszew, Poland, 05-135
Romania
Emergency University Bucharest Hospital; Oncology Department
Bucharest, Romania, 050098
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca, Romania, 400015
Oncology Inst. Cluj-Napoca; Cancer Dept
Cluj-Napoca, Romania, 400015
Euroclinic Center of Oncology SRL
Iasi, Romania, 700106
Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan, Russian Federation, 420029
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, Russian Federation, 115478
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Pyatigorsk, Russian Federation, 357502
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, Russian Federation, 355045
Tula Regional Oncology Dispensary
Tula, Russian Federation, 300053
Slovenia
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
South Africa
National Hospital; Oncotherapy Dept
Bloemfontein, South Africa, 9301
West Rand Oncology Centre; Flora Clinic
Floracliffe, South Africa, 1715
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Parktown, Johannesburg, South Africa, 2193
Steve Biko Academic Hospital; Oncology
Pretoria, South Africa, 0002
Spain
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain, 03203
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 08208
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, Spain, 39008
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
San Sebastian, Guipuzcoa, Spain, 20014
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian, Guipuzcoa, Spain, 20080
Hospital Universitario Son Espases
Palma De Mallorca, Islas Baleares, Spain, 07014
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca, Islas Baleares, Spain, 07198
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital Universitario de Canarias;servicio de Oncologia
La Laguna, Tenerife, Spain, 38320
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital Duran i Reynals; Oncologia
Barcelona, Spain, 08907
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Spain, 08916
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Spain, 12002
Hospital Universitario Reina Sofia; Servicio de Oncologia
Cordoba, Spain, 14004
Hospital Juan Ramon Jimenez;Servicio de Oncologia
Huelva, Spain, 21005
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaen, Spain, 23007
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña, Spain, 15006
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
La Coruña, Spain, 15009
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lerida, Spain, 25198
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, Spain, 28033
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, Spain, 29010
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
Murcia, Spain, 30008
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
Sevilla, Spain, 41014
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, Spain, 45004
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, Spain, 46009
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, Spain, 46015
Hospital Universitario la Fe; Servicio de Oncologia
Valencia, Spain, 46026
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Sweden
Sahlgrenska Universitetssjukhuset; Onkology
Gothenburg, Sweden, SE-41 343
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, Sweden, 58185
Karolinska University Hospital; Department of General Oncology
Stockholm, Sweden, 11883
Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology
Umea, Sweden, 90185
Akademiska sjukhuset, Onkologkliniken
Uppsala, Sweden, 75185
Switzerland
Universitaetsspital Basel; Onkologie
Basel, Switzerland, 4031
HUG; Gynécologie
Genève 14, Switzerland, 1211
Luzerner Kantonsspital; Medizinische Onkologie
Luzern, Switzerland, 6004
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen, Switzerland, 9007
Brustzentrum
Zürich, Switzerland, 8008
Taiwan
Changhua Christian Hospital; Dept of Surgery
Changhua, Taiwan, 500
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung, Taiwan, 807
Taichung Veterans General Hospital; Dept of Surgery
Taichung, Taiwan, 407
National Cheng Kung Uni Hospital; Surgery
Tainan, Taiwan, 704
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, Taiwan, 00112
National Taiwan Uni Hospital; General Surgery
Taipei, Taiwan, 100
Tri-Service General Hospital, Division of General Surgery
Taipei, Taiwan, 114
Thailand
Chiang Rai Prachanukraw Hospital; Department of Pediatrics, Faculty of Medicine
Chiang Rai, Thailand, 57000
Lopburi Cancer Hospital; Chemotherpy Unit; Chemotherapy
Lopburi, Thailand, 15000
Buddhachinaraj Phitsanulok Hospital; Hemato-oncology Unit; Department of Medicine
Phitsanulok, Thailand, 65000
Songklanagarind Hospital; Department of Surgery
Songkla, Thailand, 90110
Surat Thani Hospital
Surat Thani, Thailand, 84000
Ukraine
Cherkassy Regional Oncological Hospital
Cherkassy, Ukraine, 18009
State Medical Academy; Oncology
Dnipropetrovsk, Ukraine, 43102
Ivano-Frankivsk Regional Oncology Center
Ivano-Frankivsk, Ukraine, 76018
Kiev City Clinical Oncology Center
Kiev, Ukraine, 03115
Volyn Regional Oncology Dispensary
Lutsk, Ukraine, 43018
Lvov State Regional Oncology Medical & Diagnostic Center
Lvov, Ukraine, 79031
Ternopil State Medical Academy
Ternopil, Ukraine, 46023
United Kingdom
Royal Berkshire Hospital; Berkshire Cancer Centre
Berkshire, United Kingdom, RG1 5AN
Velindre Cancer Centre; Oncology Dept
Cardiff, United Kingdom, CF14 2TL
Cheltenham General Hospital; Gloucestershire Oncology Centre
Cheltenham, United Kingdom, GL53 7AN
Colchester General Hospital
Colchester, Essex, United Kingdom, CO4 5JL
University Hospital coventry; Oncology Department
Coventry, United Kingdom, CV2 2DX
Western General Hospital; Edinburgh Breast Unit
Edinburgh, United Kingdom, EH4 2XU
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, United Kingdom, EX2 5DW
Ipswich Hospital; Oncology Pharmacy
Ipswich, United Kingdom, IP4 5PD
St James Uni Hospital; Icrf Cancer Medicine Research Unit
Leeds, United Kingdom, LS9 7TF
St. Bartholomew'S Hospital; Dept of Medical Oncology
London, United Kingdom, EC1A 7BE
UCL Hospital NHS Trust
London, United Kingdom, NW1 2PG
Royal Marsden Hospital; Dept of Med-Onc
London, United Kingdom, SW3 6JJ
Christie Hospital; Breast Cancer Research Office
Manchester, United Kingdom, M20 4QL
Mount Vernon Hospital; Centre For Cancer Treatment
Northwood, United Kingdom, HA6 2RN
Nottingham City Hospital; Oncology
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, United Kingdom, OX3 7LJ
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough, United Kingdom, PE3 9GZ
Queen Alexandra Hospital; Haematology and Oncology Centre
Portsmouth, United Kingdom, PO6 3LY
Royal Preston Hosp; Rosemere Cancer Ctr
Preston, United Kingdom, PR2 9HT
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, United Kingdom, S10 2SJ
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
Stoke-on-Trent, United Kingdom, ST4 6QG
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
Sutton, United Kingdom, SM2 5PT
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, United Kingdom, TR1 3LJ
The Clatterbridge Cancer Ctr For Oncolgy
Wirral, United Kingdom, CH63 4JY
New Cross Hospital; Deansley Centre
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Genentech, Inc.
Breast International Group
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01358877     History of Changes
Other Study ID Numbers: BO25126
TOC4939G ( Other Identifier: Genentech )
2010-022902-41 ( EudraCT Number )
BIG 4-11 ( Other Identifier: Breast International Group )
First Posted: May 24, 2011    Key Record Dates
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018
Last Verified: November 2017

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Pertuzumab
Neoplasms by Site
Neoplasms
Skin Diseases
Paclitaxel
Docetaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Trastuzumab
Fluorouracil
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic