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A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
NCT03701334 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03701334
The ClinicalTrials.gov registry entry for NCT03701334 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 5,101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 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 2 interventions — of which Ribociclib 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: NCT03701334 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03701334?
The interventions under investigation include: Ribociclib (DRUG), Endocrine Therapy (ET) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03701334?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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