At a glance
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Preoperative Window of Opportunity Study With Giredestrant (GDC-9545) or Tamoxifen in Premenopausal Women With Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative & Ki67≥10% Early Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Giredestrant and Tamoxifen for Breast Cancer and Breast Cancer, Early-Onset. Completed, enrolled 92 participants across 18 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Giredestrant is a highly potent, non-steroidal, oral selective ER antagonist and degrader (SERD)
Tamoxifen is a selective estrogen receptor (ER) modulator