# A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

> **NCT04546009** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Hoffmann-La Roche** · enrollment: 992 (actual)

## Conditions studied

- Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

## Interventions

- **DRUG:** Giredestrant
- **DRUG:** Giredestrant-matched Placebo
- **DRUG:** Letrozole
- **DRUG:** Letrozole-matched Placebo
- **DRUG:** Palbociclib
- **DRUG:** LHRH Agonist

## Key facts

- **NCT ID:** NCT04546009
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-10-09
- **Primary completion:** 2026-01-30
- **Final completion:** 2028-03-25
- **Target enrollment:** 992 (ACTUAL)
- **Last updated:** 2026-02-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04546009

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04546009, "A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04546009. Licensed CC0.

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