Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

NCT00721409

Last updated date
Study Location
Central Hematology Oncology Medical group Inc.
Alhambra, California, 91801, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior or concomitant treatment for advanced breast cancer.


- Other major cancer in the past 3 years.


- Important cardiovascular events in the past 6 months.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Arm A
    letrozole + PD 0332991
    Interventions:
    • Drug: PD 0332991
    • Drug: letrozole
  • Active Comparator: Arm B
    letrozole
    Intervention: Drug: letrozole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
177
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2008)
165
Actual Study Completion Date  ICMJE December 20, 2017
Actual Primary Completion Date November 29, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Russian Federation,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT00721409
Other Study ID Numbers  ICMJE A5481003
2008-002392-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2019

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