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Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Trial Status: Closed to Accrual

This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer. The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer

Inclusion Criteria

  • Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
  • Patient is premenopausal or perimenopausal at the time of study entry
  • Patients who received (neo) adjuvant therapy for breast cancer are eligible
  • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
  • Patient has HER2-negative breast cancer
  • Patient must have either measurable disease or If no measurable disease is present, then at least one predominantly lytic bone lesion
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patient has adequate bone marrow and organ function

Exclusion Criteria

  • Patient who has received a prior CDK4/6 inhibitor
  • Patient is postmenopausal
  • Patients who currently have inflammatory breast cancer at screening.
  • Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
  • Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  • Patient with CNS metastases.
  • Patient has active cardiac disease or a history of cardiac dysfunction
  • Patient is currently using other antineoplastic agents
  • Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Lancaster
City of Hope Antelope Valley
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Los Angeles
Translational Research In Oncology - US Inc
Status: ACTIVE
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: COMPLETED
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
South Pasadena
City of Hope South Pasadena
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Kansas

Fairway
University of Kansas Clinical Research Center
Status: COMPLETED
Great Bend
Central Care Cancer Center - Great Bend
Status: COMPLETED
Hays
HaysMed University of Kansas Health System
Status: COMPLETED
Kansas City
University of Kansas Cancer Center
Status: COMPLETED
Pittsburg
Ascension Via Christi - Pittsburg
Status: COMPLETED
Topeka
University of Kansas Health System Saint Francis Campus
Status: COMPLETED

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
San Antonio
University of Texas Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CLEE011E2301
  • Secondary IDs NCI-2014-02508, S14-01868, 2014-001931-36
  • Clinicaltrials.gov ID NCT02278120