At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 252 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.
A STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
In Brief
A Phase 4 clinical trial evaluating Palbociclib and Letrozole for Breast Cancer. Completed, enrolled 252 participants across 34 sites in 2 countries.
Detailed Summary
A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, India
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionJul 2019
TodayJul 2026
First PostedFeb 10, 2016
Enrollment StartMar 9, 2016
Primary CompletionJul 25, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.4 years ago
Interventions
Palbociclibdrug
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