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

NCT02692755 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-09-28

Study results available
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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

Conditions

  • Hormone Receptor Positive HER-2 Negative Breast Cancer

Interventions

DRUG

Palbociclib + Letrozole or Fulvestrant

Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months

Sponsors & Collaborators

  • University of Chicago

    collaborator OTHER

  • Thomas Jefferson University

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Claudine Isaacs, MD · MedStar Georgetown University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-12-16
Completion
2021-03-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02692755 on ClinicalTrials.gov