CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
Palbociclib 100mg +2 moredrug
Likely dose
Palbociclib 100mgfrom 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/NCT02630693
NCT02630693Phase 2Completed
CompareCT.gov

Randomized Phase II Study Comparing Two Different Schedules of Palbociclib Plus Second Line Endocrine Therapy in Women With Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer

Canadian Cancer Trials Group·interventional·Posted Dec 15, 2015·Updated Apr 13, 2026

In Brief

A Phase 2 clinical trial evaluating Palbociclib 100mg, Palbociclib 125mg, and 1 other intervention for Breast Cancer. Completed, enrolled 180 participants across 22 sites.

Detailed Summary

The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 15, 2015
Enrollment StartApr 8, 2016
Primary CompletionAug 15, 2018
Study CompletionNov 29, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.5 years ago

Interventions

Palbociclib 100mgdrug

100mg PO daily

Palbociclib 125mgdrug

125mg PO daily 3 weeks out of 4

Fulvestrant or Tamoxifen or Aromatase Inhibitordrug

given at the standard doses/schedules