A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Official title

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Study identification

NCT ID

NCT06065748

Recruitment status

Recruiting

Study type

Interventional

Phase

Phase 3

Lead sponsor

Hoffmann-La Roche

Industry

Enrollment

1,050 participants

Conditions and interventions

Eligibility (public fields only)

Age range

18 Years and older

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Dec 10, 2023

Primary completion

Feb 18, 2027

Completion

Feb 11, 2029

Last update posted

May 4, 2026

2023 – 2029

United States locations

U.S. sites

61

U.S. states

30

U.S. cities

57

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 290 non-U.S. sites.