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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: letrozole; Drug: PD 0332991

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721409

A5481003

2008-002392-27 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 177 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

177 participants in 2 patient groups

Arm A

Experimental group

Description:

letrozole + PD 0332991

Treatment:

Drug: PD 0332991

Drug: letrozole

Drug: letrozole

Arm B

Active Comparator group

Description:

letrozole

Treatment:

Drug: letrozole

Drug: letrozole