Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Neurology Diabetes / Metabolic Rheumatology Gastroenterology Mental Health / Psychiatry Women's Health Dermatology Men's Health Rare Diseases
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.

Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
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
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Osimertinib for treating EGFR mutation-positive unresectable locally advanced non-small-cell lung cancer after platinum-based chemoradiotherapy
Oncology · 21 May 2026
Osimertinib is recommended by NICE for EGFR mutation-positive unresectable locally advanced NSCLC only after prior platinum-based chemoradiotherapy has been completed, making it…
View guideline →
Guideline
Zanidatamab for treating HER2-positive advanced biliary tract cancer after 1 or more lines of systemic treatment
Oncology · 07 May 2026
Zanidatamab is recommended by NICE as an option for HER2-positive advanced biliary tract cancer only after 1 or more prior lines of…
View guideline →
Guideline
Early Breast Cancer: Diagnosis and Management (NICE NG101)
Oncology · 25 Mar 2026
Perform triple assessment (clinical examination, imaging, and biopsy) for all suspicious breast lesions to confirm diagnosis before treatment planning Offer breast-conserving surgery…
View guideline →
Guideline
Oesophago-Gastric Cancer: Assessment and Management (NICE NG83)
Oncology · 27 Mar 2026
Multimodal treatment with neoadjuvant chemotherapy followed by surgical resection improves survival for locally advanced oesophago-gastric junction and gastric adenocarcinomas. HER2 testing is…
View guideline →
Guideline
Encorafenib with binimetinib for treating BRAF V600E mutation-positive advanced non-small-cell lung cancer
Oncology · 06 May 2026
Test for BRAF V600E mutation in patients with advanced NSCLC before considering encorafenib plus binimetinib, as this combination is only recommended for…
View guideline →
Guideline
2023 ESMO Clinical Practice Guideline: Early Breast Cancer
Oncology · 30 Mar 2026
Focuses on multidisciplinary management of early breast cancer including surgery, radiation, and systemic therapy • Covers genetic testing recommendations (BRCA, PD-L1, HER2)…
View guideline →