Clinical Trial

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

Active, Not Recruiting Phase 3
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Summary
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.
Protocol Amendment History 1 change
notable Trial sites reduced: 206 -> 202 locations 2026-07-17
Trial Details
NCT Number NCT05296798
Lead Sponsor Hoffmann-La Roche
Conditions Locally Advanced or Metastatic Breast Cancer
Enrollment 922 participants
Start Date 2022-07-18
Primary Completion 2027-10-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16