drugset / Trial / NCT04546009
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
RandomizedParallel-groupDouble-blindTreatment
Summary
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Timeline
- Start
- 2020-10-09
- Primary completion
- 2026-01-30
- Completion
- 2028-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Giredestrant | Small molecule | — | Oral |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Background | Palbociclib | Small molecule | 125 mg | Oral |