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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
Open (Enrolling)
Female
Breast Cancer

Thank you

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 SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteLas Vegas, Nevada  89128