At a glance
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A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), and 1 other intervention for Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer. Active but no longer recruiting, targeting 303 participants across 81 sites in 17 countries.
Signals
Detailed Summary
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.
Study Details
Timeline
Arms & Interventions
The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
Interventions
Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.
Physician choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.
Only premenopausal/perimenopausal participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.