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Trial record 1 of 1 for:    NCT00721409
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Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

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: NCT00721409
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : March 19, 2015
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: PD 0332991 Drug: letrozole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2, Open-label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Letrozole Plus Pd 0332991 (Oral Cdk 4/6 Inhibitor) And Letrozole Single Agent For The First-line Treatment Of Er Positive, Her2 Negative Advanced Breast Cancer In Postmenopausal Women
Actual Study Start Date : September 15, 2008
Actual Primary Completion Date : November 29, 2013
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A
letrozole + PD 0332991
Drug: PD 0332991
125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles

Drug: letrozole
2.5 mg/d tablets orally on a continuous regimen

Active Comparator: Arm B
letrozole
Drug: letrozole
2.5 mg/d tablets orally on a continuous regimen




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) at Phase 1 [ Time Frame: Maximum treatment duration (approximately 55 months) ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  2. Number of Participants With Treatment-Related Adverse Events at Phase 1 [ Time Frame: Maximum treatment duration (approximately 55 months) ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  3. Number of Participants With Dose Limiting Toxicities at Phase 1 [ Time Frame: Cycle 2 (4 weeks) ]
    Dose limiting toxicity was defined as any of the following TEAEs occurring during the second cycle of treatment and possibly attributable to the combination of letrozole plus Palbociclib: 1. Grade 4 hematologic toxicity (including platelets <25,000/μL, ANC <500/μL). 2. Grade 3 neutropenia associated with a documented infection or fever ≥38.5°C. 3. Grade ≥3 non-hematologic toxicities, except those that have not been maximally treated (eg, nausea, vomiting, diarrhea, hypertension). 4. Delay by ≥1 week in receiving the next scheduled dose of either study treatment due to persisting treatment-related toxicities (platelet count <50,000/μL; ANC <1,000/μL; nonhematologic toxicities of Grade ≥3 severity). 5. Inability to deliver at least 80% of the planned Palbociclib or letrozole doses during Cycle 2 due to toxicity possibly attributable to the study treatment.

  4. Progression-Free Survival (PFS) at Phase 2 - Investigator Assessment [ Time Frame: From randomization date to date of first documentation of progression or death (assessed up to 41 months) ]
    PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Weeks or Months) = (first event date minus randomization or the first dose date plus 1) divided by 7 (or 30.44 if in months). PFS is usually characterized by the median, 25% percentile,75% percentile and their 95% Confidence Intervals (CIs).


Secondary Outcome Measures :
  1. Objective Response Rate - Percentage of Participants With Confirmed Objective Tumor Response at Phase 1 [ Time Frame: From Baseline up to end of study (assessed up to 55 months) ]
    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.

  2. Percentage of Participants With Clinical Benefit Response (CBR) at Phase 1 [ Time Frame: From Baseline up to end of study (assessed up to 55 months) ]
    CBR is defined as a confirmed CR, confirmed PR, or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 weeks after initial response.

  3. Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) at Phase 1 [ Time Frame: Cycle 1 Day 14, and Cycle 2 Day 14 ]
    On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.

  4. Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Maximum Observed Plasma Concentration (Cmax) at Phase 1 [ Time Frame: Cycle 1 Day 14, and Cycle 2 Day 14 ]
    On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.

  5. Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Time to Maximum Plasma Concentration (Tmax) at Phase 1 [ Time Frame: Cycle 1 Day 14, and Cycle 2 Day 14 ]
    On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.

  6. Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Terminal Plasma Half-life (t1/2) at Phase 1 [ Time Frame: Cycle 1 Day 14, and Cycle 2 Day 14 ]
    On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.

  7. Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Clearance (CL/F) at Phase 1 [ Time Frame: Cycle 1 Day 14, and Cycle 2 Day 14 ]
    On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.

  8. Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Volume of Distribution (Vz/F) at Phase 1 [ Time Frame: Cycle 1 Day 14, and Cycle 2 Day 14 ]
    On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.

  9. Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: AUC24 at Phase 1 [ Time Frame: Cycle 2 Day 14, Cycle 2 Day 28 ]
    On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.

  10. Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Cmax at Phase 1 [ Time Frame: Cycle 2 Day 14, and Cycle 2 Day 28 ]
    On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.

  11. Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Tmax at Phase 1 [ Time Frame: Cycle 2 Day 14, and Cycle 2 Day 28 ]
    On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.

  12. Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval at Phase 1 [ Time Frame: Cycle 1 Day 1 prior to dosing, Cycle 1 Day 14 (2, 4 [prior to meal], 8, 24, 48, and 96 hours after dosing of Palbociclib), Cycle 2 Day 1 and Day 14 (prior to and 4 hours after dosing of letrozole) ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.

  13. Overall Survival (OS) at Phase 2 [ Time Frame: From randomization until death (assessed up to 86 months) ]
    Time in weeks or months from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7 or 30.44 if in months.

  14. Objective Response Rate - Percentage of Participants With Confirmed Objective Response at Phase 2- Investigator Assessment [ Time Frame: From randomization up to the end of treatment (approximately 41 months) ]
    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.

  15. Objective Response Rate - Percentage of Participants With Confirmed Objective Response in Participants With Measurable Disease at Phase 2- Investigator Assessment [ Time Frame: From randomization up to the end of treatment (approximately 41 months) ]
    Percentage of participants with objective response based assessment of confirmed CR or PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions. Measurable disease referred to the lesions that was accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10-16 mm with spiral computer tomography scan (depending on reconstruction interval). Clinical lesions were only be considered measurable when they were superficial (eg, skin nodules, palpable lymph nodes).

  16. Duration of Response at Phase 2 - Investigator Assessment [ Time Frame: From randomization up to the end of treatment (approximately 41 months) ]
    Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).

  17. Number of Participants With CBR at Phase 2 - Investigator Assessment [ Time Frame: From randomization up to the end of treatment (approximately 41 months) ]
    CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST.

  18. Time to Tumor Progression (TTP) at Phase 2-Investigator Assessment [ Time Frame: From randomization up to the end of treatment (approximately 41 months) ]
    Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).

  19. Change From Baseline in Modified Brief Pain Inventory in Pain Severity Scale (mBPI-sf) Questionnaire at Phase 2 [ Time Frame: Baseline, End of treatment (approximately 41 months) ]
    The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 ("no pain" or "does not interfere") to 10 ("pain as bad as you can imagine" or "completely interferes").

  20. Change From Baseline in Modified Brief Pain Inventory in Pain Interference Scale (mBPI-sf) Questionnaire at Phase 2 [ Time Frame: Baseline, End of treatment (approximately 41 months) ]
    The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 ("no pain" or "does not interfere") to 10 ("pain as bad as you can imagine" or "completely interferes").

  21. Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - p16/INK4A, CCND1 [ Time Frame: Screening visit (≤ 28 Days prior to dosing) ]
    Tissue samples were used for retrospective biomarker analyses. For Phase 2 Part 2, the tissue samples were sent to a central laboratory for the assessment of participant selection biomarkers. For Phase 2 Part 1, the assessment of the biomarkers (CCND1 amplification and/or loss of p16) were performed retrospectively from the available samples.

  22. Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Ki67 [ Time Frame: Screening visit (≤ 28 Days prior to dosing) ]
    Frequency of tumor tissue biomarker Ki67 was evaluated in across treatment groups.

  23. Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Tumor Retinoblastoma (RB) and CyclinD1 [ Time Frame: Screening visit (≤ 28 Days prior to dosing) ]
    Presence or absence of tumor RB and CyclinD1 were evaluated. The following definitions of expression applied in the below table: Positive: any expression >0 and Negative: any expression=0.

  24. Summary of Copy Number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) at Phase 2 [ Time Frame: Screening visit (≤ 28 Days prior to dosing) ]
    Gene copy number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) were evaluated. This analysis was done for Phase 2 combined group.

  25. Percentage of Participants With Tumor Expression of CYP19A1 and CCND1 Genotypes at Phase 2 [ Time Frame: Screening visit (≤ 28 Days prior to dosing) ]
    One 2-mL blood specimen was collected for the analysis of germline polymorphism in CYP19A1 and CCND1 genes. A single nucleotide polymorphism (SNP) rs4646 as defined in the National Center for Biotechnology Information (NCBI) database in the aromatase gene (CYP19A1) was analyzed. A germline polymorphism G/A870 (rs9344) in the CCND1 gene was analyzed.

  26. Number of Participants With TEAEs (All Causalities) at Phase 2 [ Time Frame: Baseline up to 28 days after last dose of study drug (for a maximum of 86 months) ]
    AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.AEs included both serious and non-serious AEs.SAE:AE resulting in any of following outcomes/deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience (immediate risk of dying);persistent or significant disability/incapacity;congenital anomaly.Treatment emergent AEs:events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or worsened relative to pre-treatment state.AEs were graded as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and coded using Medical Dictionary for Regulatory Activities (MedDRA). Participants with AE of grade 3 or 4 and grade 5 were reported as Grade 3:Severe, Grade 4:Life threatening, Grade 5:Death related to AE.

  27. Number of Participants With Treatment-Related Adverse Events at Phase 2 [ Time Frame: Baseline up to 28 days after last dose of study drug (for a maximum of 86 months) ]
    AE: any untoward medical occurrence in a participant who received study drug. AEs included both serious and non-serious adverse events. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs: events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Treatment related AEs: all AEs with causality related to treatment. Relatedness to drug was assessed by the investigator. AEs were graded according to the CTCAE version 3.0 and coded using the MedDRA. Number of participants with AE of grade 3 or 4 and with AE of grade 5 were reported as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inoperable estrogen receptor positive and HER2 negative breast cancer.
  • Postmenopausal status.
  • Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.
  • Acceptable bone marrow, liver and kidney function.

Exclusion Criteria:

  • Prior or concomitant treatment for advanced breast cancer.
  • Other major cancer in the past 3 years.
  • Important cardiovascular events in the past 6 months.

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): NCT00721409


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Locations
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United States, California
Central Hematology Oncology Medical group Inc.
Alhambra, California, United States, 91801
UCLA Hematology/Oncology - Alhambra
Alhambra, California, United States, 91801
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
UCLA West Medical Pharmacy (Drug Management Only)
Los Angeles, California, United States, 90095-1772
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-1772
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095-6984
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-7349
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095
Drug Management Only
Los Angeles, California, United States, 90095
Regulatory Managment
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
TORI -US Central Administration (Regulatory Management)
Los Angeles, California, United States, 90095
TORI -US Central Administration
Los Angeles, California, United States, 90095
TORI Central Administration (Regulatory Management)
Los Angeles, California, United States, 90095
TORI Central Administration (Regulatory Managment Only)
Los Angeles, California, United States, 90095
TRIO-US Central Administration
Los Angeles, California, United States, 90095
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
UCLA, Hematology/Oncology
Los Angeles, California, United States, 90095
Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles, California, United States, 90095
Central Hematology Oncology Medical Group, Inc
Pasadena, California, United States, 91107
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
Redondo Beach, California, United States, 90277
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
Santa Monica-UCLA Medical Center and Orthopaedic Hospital
Santa Monica, California, United States, 90404
UCLA Hematology Oncology-Santa Monica
Santa Monica, California, United States, 90404
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, United States, 91355
United States, Georgia
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care
Duluth, Georgia, United States, 30096
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care
Lawrenceville, Georgia, United States, 30046
Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care
Snellville, Georgia, United States, 30078
United States, Illinois
Illinois Cancer Specialists
Chicago, Illinois, United States, 60611
Resurrection Medical Group
Chicago, Illinois, United States, 60657
North Shore Oncology-Hematology Associates
Crystal Lake, Illinois, United States, 60014
North Shore Hematology Oncology
Highland Park, Illinois, United States, 60035
North Shore Oncology-Hematology Associates
Libertyville, Illinois, United States, 60048
North Shore Hematology Oncology
Skokie, Illinois, United States, 60077
United States, Nevada
Regulatory Office: Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89014
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, Texas
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Investigational Products Center (IPC)
Fort Worth, Texas, United States, 76177
US Oncology Research and Clinical Pharmacy
Fort Worth, Texas, United States, 76177
United States, Virginia
Virginia Cancer Specialists, PC
Arlington, Virginia, United States, 22205
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States, 20155
Virginia Cancer Specialists, PC
Leesburg, Virginia, United States, 20176
Virginia Cancer Specialists, PC
Woodbridge, Virginia, United States, 22191
Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Quebec
CSSS Champlain-Charles-Le Moyne Local HS-0054
Greenfield Park, Quebec, Canada, J4V 2H1
France
Centre Paul Papin, CRLCC
ANGERS Cedex 9, France, 49933
CHD Vendee
La Roche Sur Yon, France, 85925
Germany
Gemeinschaftspraxis, Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany, 14195
Gemeinschaftspraxis Haematologie-Onkologie
Dresden, Germany, 01307
Martin-Luther-Universitaet Halle-Wittenberg
Halle/Saale, Germany, 06097
Universitaetsklinik und Poliklinik fuer Gynaekologie, Martin-Luther-Universitaet Halle-Wittenberg
Halle/Saale, Germany, 06120
Nationales Centrum fuer Tumorerkrankungen
Heidelberg, Germany, 69120
Frauenaerzte Pruener Gang Abts & Partner
Kiel, Germany, 24103
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe Universitaetsklinik Mainz
Mainz, Germany, 55101
Onkolog. Gemeinschaftspraxis
Muenchen, Germany, 80335
Frauenklinik vom Roten Kreuz
Muenchen, Germany, 80637
Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen
Muenchen, Germany, 81675
Mutterhaus der Borromaeerinnen, Innere Medizin I
Trier, Germany, 54290
Hungary
Szent Margit Korhaz, Onkologia
Budapest, Hungary, 1032
Orszagos Onkologiai Intezet, Kemoterapia B
Budapest, Hungary, 1122
Fovarosi Onkormanyzat Uzsoki Utcai Korhaz
Budapest, Hungary, 1145
Petz Aladar Megyei Oktato Korhaz, Onkoradiologia
Gyor, Hungary, 9023
Borsod-Abauj-Zemplen Megyei Korhaz és Egyetemi Oktato Korhaz, Onkologia
Miskolc, Hungary, 3526
Szabolcs-Szatmar-Bereg Megyei Korhazak es
Nyiregyhaza, Hungary, 4400
Markusovszky Egyetemi Oktatokorhaz, Onkoradiologiai Osztaly
Szombathely, Hungary, 9700
Ireland
Bon Secours Hospital
Cork, Ireland
St. James's Hospital
Dublin 8, Ireland
St. Vincent's University Hospital
Dublin, Ireland, 4
Mater Misericordiae University Hospital
Dublin, Ireland, 7
Mater Private Hospital
Dublin, Ireland, 7
Italy
Divisione Oncologia Medica Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRST
Meldola, FC, Italy, 47014
M.O. di Oncologia - Azienda USL di Rimini - Ospedale "Cervesi"
Cattolica, Italy, 47841
Ospedale Civile di Faenza Centro Oncologico
Faenza, RA, Italy, 48018
Unita' Operativa di Oncologia, Ospedale Civile di Lugo
Lugo, RA, Italy, 48022
Ospedale Civile di Ravenna
Ravenna, Italy, 48100
Azienda Unita Sanitaria Locale di Rimini, U.O. di Oncologia ed Oncoematologia Ospedale degli Infermi
Rimini, Italy, 47900
Ospedale Villa San Pietro
Roma, Italy, 00189
Korea, Republic of
National Cancer Center, Center for Breast Cancer
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Russian Federation
Federal State Budgetary Scientific Institution
Moscow, Russian Federation, 115478
Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation, 357502
State Budgetary Healthcare Institution "Samara Regional Clinical Oncology Dispensary"
Samara, Russian Federation, 443031
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
Ufa, Russian Federation, 450054
South Africa
Department of Oncotherapy, National Hospital
Bloemfontein, South Africa, 9301
Eastleigh Breast Care Centre
Pretoria, South Africa, 0041
Spain
Ico-Hospitalet
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital General Universitario Vall D'Hebron
Barcelona, Spain, 08035
Centro Oncologico de Galicia
La Coruña, Spain, 15009
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen Del Rocio
Sevilla, Spain, 41013
Ukraine
Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine, "MI "Dnipropetrovsk City
Dnipropetrovsk, Ukraine, 49102
Municipal Treatment-and-Prophylactic Institution 'Donetsk City Oncological Dispensary' Radiology dep
Donetsk, Ukraine, 83087
Municipal clinical treatment-and-propyilactic institution "Donetsk regional oncology center',
Donetsk, Ukraine, 83092
Kyiv City Clinical Oncologic Center
Kyiv, Ukraine, 03115
Lviv State Oncologic Regional Treatment and Diagnostic Centre
Lviv, Ukraine, 79031
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00721409     History of Changes
Other Study ID Numbers: A5481003
2008-002392-27 ( EudraCT Number )
First Posted: July 24, 2008    Key Record Dates
Results First Posted: March 19, 2015
Last Update Posted: December 10, 2018
Last Verified: November 2018

Keywords provided by Pfizer:
hormone-receptor positive advanced breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Palbociclib
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors