CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 666 enrolled
Drug / intervention
PD-0332991 +3 moredrug
Likely dose
PD-0332991 125mgfrom 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/NCT01740427
NCT01740427Phase 3Completed
CompareCT.gov

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

Pfizer·interventional·Posted Dec 4, 2012·Updated Nov 14, 2024

In Brief

A Phase 3 clinical trial evaluating PD-0332991, Letrozole, and 1 other intervention for Breast Neoplasms. Completed, enrolled 666 participants across 305 sites in 18 countries.

Detailed Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 4, 2012
Enrollment StartFeb 22, 2013
Primary CompletionFeb 26, 2016
Study CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 13.6 years ago

Interventions

PD-0332991drug

PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Letrozoledrug

Letrozole, 2.5mg, orally once daily (continuously)

Placebodrug

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Letrozoledrug

Letrozole, 2.5mg, orally once daily (continuously)