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A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
NCT04961996 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
Conditions Studied
Interventions
- DRUG Giredestrant
- DRUG Physician's Choice of Endocrine Therapy
- DRUG LHRH Agonist
Study Locations (20)
California
- CBCC Global Research Inc., at Comprehensive Blood and Cancer Center — Bakersfield
- St Joseph Heritage Healthcare — Fullerton
- Long Beach Memorial Medical Center — Long Beach
- Cancer Blood and Specialty Clinic — Los Alamitos
- The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange — Orange
- Kaiser Permanente - San Diego — San Diego
- Sansum Clinic — Santa Barbara
- UCLA Hematology/Oncology — Santa Monica
- Torrance Memorial Physician Network/Cancer Care — Torrance
- Kaiser Permanente - Vallejo — Vallejo
Florida
- Memorial Healthcare System - Memorial Regional Hospital — Hollywood
- Baptist - MD Anderson Cancer Center — Jacksonville
- Mount Sinai Comprehensive Cancer Center — Miami Beach
Illinois
- University of Chicago Hospital — Chicago
- Duly Health and Care — Tinley Park
Alabama
- Southern Cancer Center — Daphne
Colorado
- Rocky Mountain Cancer Centers (Longmont) - USOR — Longmont
Connecticut
- Stamford Hospital — Stamford
Kansas
- Cancer Center of Kansas - Kingman — Kingman
Kentucky
- University of Kentucky — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,170 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2035-01-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04961996
The ClinicalTrials.gov registry entry for NCT04961996 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Early Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Giredestrant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04961996 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04961996 about?
NCT04961996 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)". This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive an...
What is the current status of trial NCT04961996?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 4,170 participants. The study started on 2021-08-27. Estimated completion is 2035-01-01.
What conditions does trial NCT04961996 study?
This clinical trial studies the following conditions: Early Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04961996?
The interventions under investigation include: Giredestrant (DRUG), Physician's Choice of Endocrine Therapy (DRUG), LHRH Agonist (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04961996?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04961996 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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