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NCT03701334 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Early Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 5,101
- Enrollment target
- 20
- Study locations
NCT03701334: Active Phase 3 study of Early Breast Cancer, sponsored by Novartis Pharmaceuticals.
NCT03701334 is a Phase 3 study of Early Breast Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 5,101 participants, above the 2,029-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (151% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03701334, a Phase 3 study of Early Breast Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 5,101 participants
- Enrollment target
- 20
- Study locations
Study Summary
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).
Primary Outcome
Invasive Disease-Free Survival (iDFS) is defined as the time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed locally using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
Conditions Studied
Interventions
- DRUG Ribociclib
- OTHER Endocrine Therapy (ET)
Study Locations (20)
California
- Comprehensive Blood and Cancer - Bakersfield
- UCLA Beverly Hills - Beverly Hills
- UCLA Burbank - Burbank
- Encino Research Center - Encino
- St. Jude Heritage Medical Group - Fullerton
- UCLA Hematology Oncology - Laguna Hills
- Southern CA Oncology Rsrch Alliance - Los Angeles
- Stanford University Medical Center - Palo Alto
- UCLA Pasadena HC Hemato Onco - Pasadena
- UCLA Porter Ranch Hemato and Onco - Porter Ranch
- Cancer Care Associates Medical Grp - Redondo Beach
- Sharp Memorial Hospital - San Diego
- UCSF - San Francisco
- Central Coast Medical Oncology Corporation - Santa Maria
- UCLA Santa Monica Hematology Oncology - Santa Monica
- Lundquist Inst BioMed at Harbor - Torrance
- UCLA Valencia - Valencia
Alabama
- University of Alabama at Birmingham-Kirklin Clinic - Birmingham
Arizona
- Cancer Treatment Centers of America - Goodyear
Arkansas
- St Bernards Medical Center - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,101 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2030-05-29 |
| Phase | Phase 3 |
What the registry record for NCT03701334 still lists
NCT03701334 is an interventional study that assigns participants to a tested intervention. Its 5,101 participants enrollment target places it among the larger protocols in the corpus, above the 2,029-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (151% higher).
The record links to 1 condition, with Early Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ribociclib is the first listed.
NCT03701334 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT03701334 about?
NCT03701334 is a clinical study titled "A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer". A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).
What is the current status of trial NCT03701334?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 5,101 participants. The study started on 2018-12-07. Estimated completion is 2030-05-29.
What conditions does trial NCT03701334 study?
This clinical trial studies the following conditions: Early Breast Cancer.
What interventions are being tested in trial NCT03701334?
The interventions under investigation include: Ribociclib (DRUG), Endocrine Therapy (ET) (OTHER).
Who is sponsoring clinical trial NCT03701334?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03701334 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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