Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer

• Status: Completed
• Trial end date: 2021-03-23
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer. Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborators: Hackensack University Medical Center; Thomas Jefferson University; University of Alabama at Birmingham; University of Chicago
• Treatments: Fulvestrant; Letrozole; Palbociclib

Criteria

Inclusion Criteria:

1. Self-identified Black, African or African American women of ≥ 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)

2. ER-positive and/or PgR-positive tumor based on local laboratory results

3. HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)

4. Patients must be appropriate candidates for letrozole or fulvestrant therapy

5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

6. Adequate bone marrow function:

• Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 (1.0 x 109/L);

• Platelets ≥100,000/mm3 (100 x 109/L);

• Hemoglobin ≥9 g/dL (90 g/L).

Exclusion Criteria:

1. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4

2. Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.

3. Previous CDK4/6 inhibitor

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