# 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)

> **NCT06065748** · PHASE3 · RECRUITING · sponsor: **Hoffmann-La Roche** · enrollment: 1050 (estimated)

## Conditions studied

- Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

## Interventions

- **DRUG:** Giredestrant
- **DRUG:** Fulvestrant
- **DRUG:** Abemaciclib
- **DRUG:** Palbociclib
- **DRUG:** Ribociclib
- **DRUG:** LHRH Agonist
- **DIAGNOSTIC_TEST:** FoundationOne Liquid CDx Assay (F1LCDx)

## Key facts

- **NCT ID:** NCT06065748
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-12-11
- **Primary completion:** 2027-02-19
- **Final completion:** 2029-02-12
- **Target enrollment:** 1050 (ESTIMATED)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06065748

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06065748, "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)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT06065748. Licensed CC0.

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