drugset / Trial / NCT02296801
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
Phase 2
Completed
307 enrolled
NSABP Foundation Inc
Institute of Cancer Research, United Kingdom · collabPfizer · collabRoyal Marsden NHS Foundation Trust · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2018-07
- Completion
- 2019-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |