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
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 1 : overall safety profile of PD 0332991 in combination with letrozole
Outcome Time Frame:
14 months
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A5481003
NCT ID:
NCT00721409
Start Date:
September 2008
Completion Date:
July 2018
Related Keywords:
- Breast Cancer
- hormone-receptor positive advanced breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Las Vegas, Nevada 89128 |
