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

• Status: Completed
• Trial end date: 2017-12-20
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Letrozole; Palbociclib

Criteria

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.