Trial Profile

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 27 Jun 2025

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At a glance

Drugs Docetaxel (Primary) ; Giredestrant (Primary) ; Hyaluronidase (Primary) ; Paclitaxel (Primary) ; Pertuzumab/trastuzumab (Primary) ; Aromatase inhibitors; LHRH receptor agonists; Tamoxifen
Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
Focus Registrational; Therapeutic Use
Acronyms heredERA Breast Cancer
Sponsors Roche

03 Mar 2025 Planned primary completion date changed from 31 Mar 2027 to 31 Dec 2027.
04 Feb 2025 Timeframe for primary endpoints changed from 50 months to 53 months.
04 Feb 2025 Planned number of patients changed from 812 to 922.

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