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)

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.

Timeline

Start

2022-07-18

Primary completion

2027-10-31

Completion

2030-12-31

Publications

• Kuemmel S, Harper-Wynne C, Park YH, Franke F, de Laurentiis M, Schumacher-Wulf E, Eiger D, Heeson S, Cardona A, Ozyilkan O, Morales-Vasquez F, Metcalfe C, Hafner M, Restuccia E, O'Shaughnessy J. heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer. BMC Cancer. 2024 May 24;24(1):641. doi: 10.1186/s12885-024-12179-9.

Drugs

Indications