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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Letrozole; Palbociclib

Criteria

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