Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05659563
Study type	Interventional
Source	MedSIR
Contact	Ana Garrido
Phone	667 762 735
Email	ana.garrido@medsir.org
Status	Recruiting
Phase	Phase 2
Start date	July 20, 2023
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms