At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 177 enrolled
Drug / intervention
PD 0332991 +2 moredrug
Likely dose
PD 0332991 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.
PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
In Brief
A Phase 2 clinical trial evaluating PD 0332991 and letrozole for Breast Cancer. Completed, enrolled 177 participants across 104 sites in 12 countries.
Detailed Summary
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, France, Germany, Hungary, Ireland, Italy, Russia, South Africa, South Korea, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartSep 2008
Primary CompletionNov 2013
Study CompletionDec 2017
TodayJul 2026
First PostedJul 24, 2008
Enrollment StartSep 15, 2008
Primary CompletionNov 29, 2013
Study CompletionDec 20, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.9 years ago
Interventions
PD 0332991drug
125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
letrozoledrug
2.5 mg/d tablets orally on a continuous regimen
letrozoledrug
2.5 mg/d tablets orally on a continuous regimen