CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Palbociclib +1 moredrug
Likely dose
Palbociclib 125 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/NCT02499146
NCT02499146Phase 1Completed
CompareCT.gov

A PHASE 1 OPEN-LABEL PHARMACOKINETICS STUDY OF PALBOCICLIB, A CYCLIN-DEPENDENT KINASE 4 AND 6 (CDK4/6) INHIBITOR, IN POSTMENOPAUSAL CHINESE WOMEN WITH ER (+), HER2 (-) ADVANCED BREAST CANCER

Pfizer·interventional·Posted Jul 15, 2015·Updated Feb 11, 2026

In Brief

A Phase 1 clinical trial evaluating Palbociclib and Letrozole for Advanced Breast Cancer. Completed, enrolled 26 participants across 7 sites.

Detailed Summary

As part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health Authorities, is therefore warranted. In addition, safety and efficacy will be also evaluated. The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be characterized.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Breast Cancer
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 15, 2015
Enrollment StartSep 11, 2015
Primary CompletionJul 31, 2018
Study CompletionDec 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.0 years ago

Interventions

Palbociclibdrug

125 mg orally once daily with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle

Letrozoledrug

2.5 mg , orally once daily (continuously)