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

Plain-language summary

This study compares Letrozole, with or without Palbociclib (PD-0332991), as first-line treatment in postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer. It included patients with inoperable tumors. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Pfizer

Intervention

PD 0332991, letrozole, letrozole

Start date

9/15/2008

Estimated completion

12/20/2017

Countries

United States, Canada, France, Germany, Hungary, Ireland, Italy, Russia, South Africa, South Korea, Spain, Ukraine

Related genes

Locations

• Alhambra, United States
• Alhambra, United States
• Bakersfield, United States
• Fullerton, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Pasadena, United States
• Redondo Beach, United States
• Santa Barbara, United States
• Santa Maria, United States
• Santa Monica, United States
• Santa Monica, United States
• Valencia, United States
• Duluth, United States
• Lawrenceville, United States
• Snellville, United States
• Chicago, United States
• Chicago, United States
• Crystal Lake, United States
• Highland Park, United States
• Libertyville, United States
• Skokie, United States
• Henderson, United States
• Henderson, United States
• Henderson, United States
• Las Vegas, United States

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.