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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech, Inc.
Breast International Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358877
First received: May 20, 2011
Last updated: September 1, 2016
Last verified: August 2016

May 20, 2011
September 1, 2016
November 2011
December 2023   (final data collection date for primary outcome measure)
  • Invasive Disease-Free Survival (IDFS) Duration (Excluding Second Primary Non-Breast Cancers as IDFS Event), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization until protocol defined IDFS event (excluding second primary non-breast cancers) (up to 12 years overall) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Both a Heart Failure of New York Heart Association (NYHA) Class III or IV and a Drop in Left Ventricular Ejection Fraction (LVEF) of at least 10 Points from Baseline and to Below 50 Percent (%) [ Time Frame: Baseline up to 12 years (assessed every 12 weeks up to first 12 months; months 18, 24, 30, 36, 48, 60 and every 12 months thereafter up to 12 years overall) ] [ Designated as safety issue: No ]
Invasive disease-free survival (IDFS) [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01358877 on ClinicalTrials.gov Archive Site
  • IDFS Duration (Including Second Primary Non-Breast Cancers as IDFS Event), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization until protocol defined IDFS event (including second primary non-breast cancers) (up to 12 years overall) ] [ Designated as safety issue: No ]
  • Disease-Free Survival (DFS) Duration (Including Second Primary Non-Breast Cancers or Contralateral or Ipsilateral Ductal Carcinoma in-Situ as an Event), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization until protocol defined DFS event (including second primary non-breast cancers or contralateral or ipsilateral ductal carcinoma in-situ) (up to 12 years overall) ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Randomization until death due to any cause (up to 12 years overall) ] [ Designated as safety issue: No ]
  • Recurrence-Free Interval (RFI), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization until local, regional or distant breast cancer recurrence (up to 12 years overall) ] [ Designated as safety issue: No ]
  • Distant Recurrence-Free Interval (DRFI), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings [ Time Frame: Randomization until distant breast cancer recurrence (up to 12 years overall) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 12 years ] [ Designated as safety issue: No ]
  • Percentage of Participants with Asymptomatic or Mildly Symptomatic (NYHA Class II) Drop in Left Ventricular Ejection Fraction (LVEF) of at least 10 Points from Baseline and to Below 50% [ Time Frame: Baseline up to 12 years (assessed every 12 weeks up to first 12 months; months 18, 24, 30, 36, 48, 60 and every 12 months thereafter up to 12 years overall) ] [ Designated as safety issue: No ]
  • LVEF Measurements Over the Course of the Study [ Time Frame: Baseline up to 12 years (assessed every 12 weeks up to first 12 months; months 18, 24, 30, 36, 48, 60 and every 12 months thereafter up to 12 years overall) ] [ Designated as safety issue: No ]
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score [ Time Frame: Baseline, Weeks 10, 13, 19, and 25; 28-days after last dose of study medication (Week 56); and Months 18, 24, and 36 ] [ Designated as safety issue: No ]
  • European Organisation for Research and Treatment of Cancer Breast Cancer Module Quality of Life (EORTC QLQ BR23) Functional Scale Score [ Time Frame: Baseline, Weeks 10, 13, 19, and 25; 28-days after last dose of study medication (Week 56); and Months 18, 24, and 36 ] [ Designated as safety issue: No ]
  • European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Score [ Time Frame: Baseline, Weeks 10, 13, 19, and 25; 28-days after last dose of study medication (Week 56); and Months 18, 24, and 36 ] [ Designated as safety issue: No ]
  • IDFS including second non-breast cancer [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS), including second non-breast cancer or contralateral or ipsilateral ductal carcinoma in situ [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Recurrence-free interval (RFI): time between randomization and local, regional or distant breast cancer recurrence [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Distant recurrence-free interval (DRFI): time between randomization and distant breast cancer recurrence [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Cardiac and overall safety: Incidence of adverse events [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Quality of life: EORTC QLQ-C30, QLQ-BR23 and EQ-5D questionnaires [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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
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. After surgery, participants will be randomized to receive either pertuzumab or placebo intravenously (IV) every 3 weeks (q3w) for one year, along with 6-8 cycles of chemotherapy and 1 year of trastuzumab IV every 3 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: 5-Fluorouracil
    Participants may receive 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) IV q3w.
  • Drug: Carboplatin
    Participants may receive carboplatin dose of 6 times Area Under the Concentration Time Curve (AUC) (maximum dose of 900 mg) IV q3w.
  • Drug: Cyclophosphamide
    Participants may receive cyclophosphamide 500-600 mg/m^2 IV q3w.
  • Drug: Docetaxel
    Participants may receive docetaxel either 75 mg/m^2 IV q3w, or 100 mg/m^2 IV q3w, or 75 mg/m^2 IV q3w for first cycle followed by 100 mg/m^2 IV q3w.
  • Drug: Doxorubicin
    Participants may receive doxorubicin 50 mg/m^2 IV q3w.
  • Drug: Epirubicin
    Participants may receive epirubicin 90-120 mg/m^2 IV q3w.
  • Drug: Paclitaxel
    Participants may receive paclitaxel 80 mg/m^2 IV once weekly.
  • Drug: Pertuzumab
    Participants will receive pertuzumab loading dose of 840 mg IV in Cycle 1, followed by 420 mg IV q3w.
  • Drug: Placebo
    Participants will receive pertuzumab matching placebo IV q3w.
  • Drug: Trastuzumab
    Participants will receive trastuzumab at a loading dose of 8 milligrams per kilogram (mg/kg) followed by 6 mg/kg IV q3w.
    Other Name: Herceptin
  • Experimental: Pertuzumab + Trastuzumab + Chemotherapy
    Participants will receive pertuzumab IV and trastuzumab IV q3w for 1 year of treatment in combination with chemotherapy according to one of the following schedules (as per Investigator's discretion): 1) 3-4 cycles (q3w) of 5-fluorouracil + epirubicin or doxorubicin + cyclophosphamide followed by either 4 cycles (q3w) of docetaxel or 12 weekly cycles of paclitaxel. 2) 4 cycles (q3w) of doxorubicin or epirubicin + cyclophosphamide followed by either 4 cycles (q3w) of docetaxel or 12 weekly cycles of paclitaxel. 3) (Non-Anthracycline therapy) 6 cycles (q3w) of docetaxel + carboplatin.
    Interventions:
    • Drug: 5-Fluorouracil
    • Drug: Carboplatin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
    • Drug: Doxorubicin
    • Drug: Epirubicin
    • Drug: Paclitaxel
    • Drug: Pertuzumab
    • Drug: Trastuzumab
  • Placebo Comparator: Placebo + Trastuzumab + Chemotherapy
    Participants will receive placebo IV and trastuzumab IV q3w for 1 year of treatment in combination with chemotherapy according to one of the following schedules (as per Investigator's discretion): 1) 3-4 cycles (q3w) of 5-fluorouracil + epirubicin or doxorubicin + cyclophosphamide followed by either 4 cycles (q3w) of docetaxel or 12 weekly cycles of paclitaxel. 2) 4 cycles (q3w) of doxorubicin or epirubicin + cyclophosphamide followed by either 4 cycles (q3w) of docetaxel or 12 weekly cycles of paclitaxel. 3) (Non-Anthracycline therapy) 6 cycles (q3w) of docetaxel + carboplatin.
    Interventions:
    • Drug: 5-Fluorouracil
    • Drug: Carboplatin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
    • Drug: Doxorubicin
    • Drug: Epirubicin
    • Drug: Paclitaxel
    • Drug: Placebo
    • Drug: Trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4806
December 2023
December 2023   (final data collection date for primary outcome measure)

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
  • 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
  • Known hormone receptor status (estrogen receptor and progesterone receptor)
  • Baseline LVEF greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
  • Confirmed HER2 positive status
  • 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 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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   El Salvador,   France,   Germany,   Guatemala,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Panama,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Ukraine,   United Kingdom
Brazil,   India,   Slovakia
 
NCT01358877
BO25126, TOC4939G, 2010-022902-41, BIG 04-11
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
  • Genentech, Inc.
  • Breast International Group
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP