NCT05659563

Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, international, open-label, two-arms, one stage, phase II, preoperative window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) as single agent in ER\[+\]/HER2\[-\] early breast cancer patients with Ki67 ≥ 10%. Upon meeting all selection criteria, 92 patients enrolled in the study will receive either giredestrant (GDC-9545) 30 mg or tamoxifen . A total of 92 patients will be enrolled as follows: * 46 patients in the investigational Arm A will receive giredestrant \[GDC-9545\] 30 mg. It will be administered orally once a day during 15 days. * 46 patients in the control Arm B will receive tamoxifen 20 mg. It will be administered orally once a day during 15 days. Patients can take both treatments at home. The main objective is to analyze the efficacy of giredestrant (GDC-9545) according to changes in tumor cell proliferation. This analysis will compare absolute changes for Ki67 expression between baseline score and the evaluation after 15 days of treatment. Total study duration is 15 days of treatment and until 28 days after the last dose of the study treatment (or discontinuation) of follow up.

Conditions

• Breast Cancer
• Breast Cancer, Early-Onset

Interventions

Type	Name	Description
DRUG	Giredestrant	Giredestrant is a highly potent, non-steroidal, oral selective ER antagonist and degrader (SERD)
DRUG	Tamoxifen	Tamoxifen is a selective estrogen receptor (ER) modulator

Timeline

• Start date: 2023-07-20
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2022-12-21
• Last updated: 2026-03-19
• Results posted: 2026-03-19

Locations

18 sites across 2 countries: France, Spain