CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 35 enrolled
Drug / intervention
Palbociclib + Letrozole or Fulvestrantdrug
Likely dose
Palbociclib + Letrozole or Fulvestrant 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02692755
NCT02692755Phase 3Completed
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Phase II Safety Study of Palbociclib in Combination With Letrozole or Fulvestrant in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

Georgetown University·interventional·Posted Feb 26, 2016·Updated Sep 28, 2021

In Brief

A Phase 3 clinical trial evaluating Palbociclib + Letrozole or Fulvestrant for Hormone Receptor Positive HER-2 Negative Breast Cancer. Completed, enrolled 35 participants across 6 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHormone Receptor Positive HER-2 Negative Breast Cancer
CountriesUnited States
CollaboratorsUniversity of Chicago, Thomas Jefferson University

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 26, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 16, 2019
Study CompletionMar 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.3 years ago

Interventions

Palbociclib + Letrozole or Fulvestrantdrug

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