# 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)

Source: https://onco.cc/trials/nct06065748/  
OnCo record `nct06065748` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Giredestrant, Fulvestrant, Abemaciclib, Palbociclib and Ribociclib in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.

## Summary

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) is a phase 3 interventional study registered as NCT06065748 by Hoffmann-La Roche, with 1050 participants enrolled, started 2023-12-11 and due to reach its primary completion in 2028-04-20. Interventions recorded: Giredestrant, Fulvestrant, Abemaciclib, Palbociclib, Ribociclib and LHRH Agonist.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06065748
- Phase: 3
- Setting: 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
- Sponsor: Hoffmann-La Roche
- Enrolled: 1050

## Sources

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

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [Abemaciclib](https://onco.cc/drugs/abemaciclib/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Giredestrant](https://onco.cc/drugs/giredestrant/), [Palbociclib](https://onco.cc/drugs/palbociclib/), [Ribociclib](https://onco.cc/drugs/ribociclib/)
- companies: [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)

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JSON: https://onco.cc/api/v1/entities/nct06065748.json