Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

Pfizer

Status

Conditions: Advanced Breast Cancer (Female)

Treatments: Drug: Palbociclib; Drug: Letrozole

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02142868

A5481034

Details and patient eligibility

About

To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).

Full description

This study is currently available in Canada only.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
• ER-positive and/or PR-positive tumor based on local laboratory results
• HER2-negative tumor based on local laboratory results
• Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)

Exclusion criteria

• Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor