A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acel

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Aromatase Inhibitors; Fulvestrant

Criteria

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