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NCT02941926 · ClinicalTrials.gov registry record · Phase 3

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

A Phase 3 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
3,246
Enrollment target
20
Study locations

NCT02941926 is a Phase 3 study of Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 3,246 participants, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT02941926, a Phase 3 study of Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
3,246 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

Conditions Studied

Interventions

  • DRUG Letrozole
  • DRUG Goserelin
  • DRUG Ribociclib
  • DRUG Leuprolide

Study Locations (20)

California

  • Beverly Hills Cancer Center - Beverly Hills
  • Pacific Shores Medical Group SC - Long Beach
  • USC Norris Cancer Center - Los Angeles
  • University of California Irvine UC Irvine (11) - Orange
  • Ventura County Hematology and Oncology - Oxnard
  • PCR Oncology - Pismo Beach
  • California Pacific Medical Center Onc Dept - San Francisco

Florida

  • Florida Cancer Research Institute Dept of Oncology - Davie
  • Foundation for Sickle Cell Disease Research - Hollywood
  • Watson Clinic Center for Research 1730 Location - Lakeland
  • Mid Florida Hematology and Onc Ctr - Orange

Arizona

  • Ironwood Cancer and Research Centers - Chandler
  • Arizona Oncology Associates - Phoenix
  • Arizona Oncology Associates Arizona Oncology Assoc. (2) - Tucson

Colorado

  • Centura Health Research Center Centura Health Research Center - Denver
  • Poudre Valley Hospital Poudre Valley Health System - Fort Collins
  • Valley View Hospital Cancer Center - Glenwood Springs

Alaska

  • Alaska Cancer Research and Education Center - Anchorage

Arkansas

  • Highlands Oncology Group - Fayetteville

Georgia

  • Summit Cancer Care Summit Cancer Care (SC) - Savannah

Trial Details

FieldValue
Enrollment Target 3,246 participants
Start Date 2016-11-30
Est. Completion 2022-11-09
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT02941926

The ClinicalTrials.gov registry entry for NCT02941926 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,246 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (16% 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 Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Letrozole is the first listed.

NCT02941926 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT02941926 about?

NCT02941926 is a clinical study titled "Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC". The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

What is the current status of trial NCT02941926?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,246 participants. The study started on 2016-11-30. Estimated completion is 2022-11-09.

What conditions does trial NCT02941926 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT02941926?

The interventions under investigation include: Letrozole (DRUG), Goserelin (DRUG), Ribociclib (DRUG), Leuprolide (DRUG).

Who is sponsoring clinical trial NCT02941926?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02941926 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. 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.