Overview

Preoperative Window of Opportunity Study With Giredestrant (GDC-9545) or Tamoxifen in Premenopausal Women With ER[+]/HER2[-] & Ki67≥10% Early Breast Cancer

Status:
Not yet recruiting

Trial end date:
2024-10-01

Target enrollment:

Participant gender:

Summary

This study is a window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) or tamoxifen in estrogen receptor-positive (ER[+])/human epidermal growth factor receptor 2-negative (HER2[-]) primary invasive adenocarcinoma of the breast with Ki67 level ≥ 10%. A total of 92 patients will be enrolled in this trial and randomized 1:1 in the arm A with giredestrant (GDC-9545) and the arm B with tamoxifen, with a total duration of treatment of 15 days. This study will analyze the efficacy of giredestrant (GDC-9545) as determined by Ki67 expression between baseline tumor biopsy samples and post-treatment biopsy samples.

Phase:

Phase 2

Details

Lead Sponsor:

MedSIR

Treatments:

Tamoxifen