A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in... | NCT04546009 | Trialant

Active, not recruitingInterventionalPhase 3Updated Aug 17, 2026

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 Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT04546009
Lead Sponsor: Hoffmann-La RocheINDUSTRY
Overall Status: Active, not recruiting
Study Type: Interventional
Phase: Phase 3
Enrollment: 992Actual
Last Update Posted: Aug 17, 2026Actual
Start Date: Oct 9, 2020Actual
Primary Completion Date: Jan 30, 2026Actual
Completion Date: Jul 31, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Brief Summary: 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

The medical conditions and diseases this study investigates.

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

Interventions

The treatments and procedures being evaluated in this study.

Giredestrant
Giredestrant-matched Placebo
Letrozole

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment

Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent

Documented ER-positive tumor and HER2-negative tumor, assessed locally

Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry

No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease

Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months

Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed

Eastern Cooperative Oncology Group Performance Status 0-1

Adequate organ function

Exclusion Criteria:

Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor

Prior treatment with a selective estrogen receptor degrader (SERD)

Treatment with any investigational therapy within 28 days prior to study treatment

Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization

Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term

Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease

Active cardiac disease or history of cardiac dysfunction, as defined in the protocol

Pregnant or breastfeeding

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Orange Coast Memorial Medical Center

Fountain Valley, California 92708, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Hoffmann-La RocheINDUSTRY

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