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Clinical Trial Active — Not Recruiting Phase III 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)

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…

📅 19 May 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT04546009
Start
2020-10-09
Completion
2026-01-30
ClinicaliQ Trial Snapshot
  • 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) — Active Not Recruiting • Phase III • Oncology….
  • persevERA Trial Summary.
  • A new breast cancer drug (giredestrant) plus palbociclib compared to standard treatment (letrozole) plus palbociclib in advanced hormone-receptor-positive breast cancer.

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What This Trial Is Studying

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer. Conditions: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Interventions: Giredestrant, Giredestrant-matched Placebo, Letrozole, Letrozole-matched Placebo, Palbociclib, LHRH Agonist Lead Sponsor: Hoffmann-La Roche Planned Enrollment: 992 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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