Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Early Breast Cancer, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT04961996 still lists
NCT04961996 is an interventional study that assigns participants to a tested intervention. Its 4,170 participants enrollment target places it among the larger protocols in the corpus, above the 2,340-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (78% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Early Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
RECRUITING · Phase 3
-
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06593353 · 4,165 participants · NA
Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail
- NCT02693535 · 4,200 participants · Phase 2
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
- NCT05969028 · 4,200 participants · NA
First Responder Airway & Compression Rate Trial
- NCT06935370 · 4,200 participants · Phase 3
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI