Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
Completed · Phase 2/Phase 3
Conditions studied: Hormone Receptor Positive HER-2 Negative Breast Cancer
In brief
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
Key facts
- Study ID
- NCT02692755
- Run by
- Georgetown University
- People needed
- 35
- Starts
- 2016-09-01
- Expected to finish
- 2021-03-23
- Last updated by the study team
- 2021-09-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- ER-positive and/or PgR-positive tumor based on local laboratory results
- HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)
- Patients must be appropriate candidates for letrozole or fulvestrant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- 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).
You may not qualify if…
- Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
- Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.
- Previous CDK4/6 inhibitor
Where it is running
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- University of Chicago — Chicago, Illinois, United States
- MedStar Union Memorial Hospital — Baltimore, Maryland, United States
- MedStar Good Samaritan Hospital — Baltimore, Maryland, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.