CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Palbociclibdrug
Likely dose
Not stated in 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/NCT03065621
NCT03065621Phase 2Completed
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Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer

Jules Bordet Institute·interventional·Posted Feb 28, 2017·Updated Apr 19, 2023

In Brief

A Phase 2 clinical trial evaluating Palbociclib for Breast Cancer Female. Completed, enrolled 100 participants across 5 sites.

Detailed Summary

This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously (each cycle of endocrine therapy consists of treatment from D1 to D28). The endocrine therapy will be determined according to the menopausal status of the subject evaluated at the study screening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer Female
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 28, 2017
Enrollment StartJul 5, 2017
Primary CompletionMar 28, 2019
Study CompletionFeb 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.3 years ago

Interventions

Palbociclibdrug

Each cycle will be 28 days. Patient will take study drug daily during 21 days and then have a rest period of 7 days.