A study to Evaluate Efficacy and Safety of Giredestrant Compared with Fulvestrant (plus a CDK4/6 inhibitor), in Participants with ER+ HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Phase 1

Recruiting

• Conditions: Estrogen receptor (ER)-positive, HER2-negative advanced breast cancer; MedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10072737Term: Advanced breast cancer Class: 10029104; MedDRA version: 23.0Level: LLTClassification code: 10070575Term: Estrogen receptor positive breast cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502980-39-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

2. Confirmed ESR1 mutation status in baseline ctDNA, 3. Resistance to prior standard adjuvant ET, defined as relapse on-treatment after = 12 months or off-treatment within 12 months of completion. If adjuvant ET included a CDK4/6i, relapse should have occurred = 12 months since completion of CDK4/6i treatment, 4. Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease, 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, 1. Locally advanced or metastatic adenocarcinoma of the breast not amenable to treatment with curative intent, with documented ER+ HER2- status assessed locally based on the most recent tumor biopsy (or archived tumor sample)

Exclusion Criteria

2. Prior treatment with a SERD (e.g., fulvestrant, investigational), 3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications, 4. Active cardiac disease or history of cardiac dysfunction, 5. Clinically significant history of liver disease, 1. Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified