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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 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.

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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).

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

FieldValue
Enrollment Target 5,101 participants
Start Date 2018-12-07
Est. Completion 2030-05-29
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT03701334

The ClinicalTrials.gov registry entry for NCT03701334 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 5,101 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,029-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (151% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 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 2 interventions - of which Ribociclib is the first listed.

NCT03701334 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.