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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

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NCT00721409

Last updated on December 13, 2018
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FOR MORE INFORMATION
Study Location
Central Hematology Oncology Medical group Inc.
Alhambra, California, 91801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00721409
Pfizer
Completed
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

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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
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
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • 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
  • Experimental: Arm A
    letrozole + PD 0332991
    Interventions:
    • Drug: PD 0332991
    • Drug: letrozole
  • Active Comparator: Arm B
    letrozole
    Intervention: Drug: letrozole


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
177
January 5, 2018
November 29, 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Russian Federation,   South Africa,   Spain,   Ukraine,   United States
Australia
 
NCT00721409
A5481003
2008-002392-27 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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