Phase 3
Completed N=35
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
Source: ClinicalTrials.gov NCT02692755 ↗
Enrolled (actual)
35
Serious AEs
22.9%
Results posted
Aug 2021
Primary outcomePrimary: Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event — 35 Participants
◆ Published Evidence
Emerging
19citations · ~4 / year
Hematologic safety of palbociclib in combination with endocrine therapy in patients with benign ethnic neutropenia and advanced breast cancer.
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
Linked Publications
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Hematologic safety of palbociclib in combination with endocrine therapy in patients with benign ethnic neutropenia and advanced breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event |
35 | — |
| SECONDARY Dose Delays in Palbociclib Attributed to Neutropenia |
17 | — |
| SECONDARY Dose Reductions in Palbociclib Therapy Attributed to Neutropenia |
13 | — |
| SECONDARY Clinical Benefit Rate |
23 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
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Data sourced from ClinicalTrials.gov (NCT02692755) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.