A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment

ClinicalTrials.gov ID: NCT07827573

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Official title

A Phase IIIb, Single-arm, Open-Label, Multicenter Study Evaluating the Treatment Adherence, Tolerability, and Patient-Reported Outcomes of Giredestrant in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant. The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.

Study identification

NCT ID: NCT07827573
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 1,500 participants

Conditions and interventions

Conditions

Interventions

Giredestrant Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 30, 2026 (Estimated)
Primary completion: Nov 30, 2028 (Estimated)
Completion: Nov 30, 2032 (Estimated)
Last update posted: Nov 12, 2026

2026 – 2032

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Hematology Oncology Salem	Salem	Oregon	97301	Recruiting
Virginia Cancer Institute	Richmond	Virginia	23229	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07827573, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 12, 2026 · Synced Nov 13, 2026