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

WO42312

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.

2020-11-27

2022-02-18

2024-06-27

Active (not recruiting)

Early phase I

303

Inclusion Criteria: * Women who are postmenopausal or premenopausal/perimenopausal * For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment * Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent * Documented ER-positive tumor and HER2-negative tumor, assessed locally * Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting * Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization * Treatment with any investigational therapy within 28 days prior to randomization * Advanced, symptomatic, visceral spread that is at risk of life-threatening complications * Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease * Active cardiac disease or history of cardiac dysfunction * Pregnant or breastfeeding

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 303, 'type': 'ACTUAL'}}

2024-02-28