At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 307 enrolled
Drug / intervention
Letrozole +1 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 Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Letrozole and palbociclib for Breast Cancer and 2 related conditions. Completed, enrolled 307 participants across 52 sites in 3 countries.
Detailed Summary
This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Carcinoma, Breast Tumors
CountriesCanada, United Kingdom, United States
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartJan 2015
Primary CompletionJul 2018
Study CompletionMar 2019
TodayJul 2026
First PostedNov 20, 2014
Enrollment StartJan 1, 2015
Primary CompletionJul 1, 2018
Study CompletionMar 1, 2019
TodayJul 1, 2026
Enrollment to primary: 3.5 yearsPosted 11.6 years ago
Interventions
Letrozoledrug
palbociclibdrug