At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 486 enrolled
Drug / intervention
Palbociclib +2 moredrug
Likely dose
Not stated in 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 Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Palbociclib, Fulvestrant, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 486 participants across 48 sites in 7 countries.
Detailed Summary
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesCzechia, France, Germany, Italy, Russia, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartAug 2015
Primary CompletionJan 2020
TodayJul 2026
First PostedJul 8, 2015
Enrollment StartAug 1, 2015
Primary CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.0 years ago
Interventions
Palbociclibdrug
Fulvestrantdrug
Letrozoledrug