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NCT04961996 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Early Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 4,170
- Enrollment target
- 20
- Study locations
NCT04961996 is a Phase 3 study of Early Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 4,170 participants, above the 2,340-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT04961996, a Phase 3 study of Early Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 4,170 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 4,170 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,340-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (78% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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.
NCT04961996 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Illinois.
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.
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).
Who is sponsoring clinical trial NCT04961996?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.