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

A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

ClinicalTrials.gov Identifier: NCT02278120

Novartis Reference Number: CLEE011E2301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Advanced Metastatic Breast Cancer
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
672 participants
Start date 
Nov 20, 2014
Completion date 
Dec 21, 2021
Gender 
Female
Age(s)
18 Years - 59 Years (Adult)

Interventions

Drug
LEE011
LEE011 600 mg daily oral
Drug
Tamoxifen
tamoxifen 20 mg daily oral
Drug
Letrozole
letrozole 2.5 mg daily oral
Drug
Anastrozole
anastrozole 1 mg daily oral
Drug
Goserelin
Goserelin 3.6 mg subcutaneous injection
Drug
LEE011 Placebo
LEE011 placebo 600 mg daily oral

Eligibility Criteria

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

Other protocol-defined Inclusion/Exclusion may apply.

Study Locations

United States
Comprehensive Blood and Cancer Center SC-2
-
Bakersfield, 93309
California
United States
University of California at Los Angeles Dept of Onc
-
Los Angeles, 90095
California
United States
Comprehensive Cancer Center at Saint Joseph Hospital SC
-
Denver, 80218
Colorado
United States
Danbury Hospital SC
-
Danbury, 06810
Connecticut
United States
Florida Cancer Specialists Onc Dept
-
Fort Myers, 33901
Florida
United States
Florida Cancer Specialists SC-2
-
Fort Myers, 33901
Florida
United States
Memorial Cancer Institute SC
-
Hollywood, 33021
Florida
United States
University of Miami Univ Miami 2
-
Miami, 33136
Florida
United States
NorthWest Georgia Oncology Centers NW Georgia Oncology
-
Marietta, 30060
Georgia
United States
Moanalua Medical Center. Attn: Oncology Dept SC
-
Honolulu, 96817
Hawaii
United States
University of Chicago SC-3
-
Chicago, 60637
Illinois
United States
Norton Cancer Institute SC
-
Louisville, 40202
Kentucky
United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Dept of Onc.
-
Baltimore, 21231
Maryland
United States
Massachusetts General Hospital Onc Dept
-
Boston, 02114
Massachusetts
United States
University of Michigan Comprehensive Cancer Center Onc Dept
-
Ann Arbor, 48109
Michigan
United States
Washington University School of Medicine SC
-
Saint Louis, 63110
Missouri
United States
Meridian Health Systems SC
-
Neptune, 07754
New Jersey
United States
University of New Mexico Hospital SC-2
-
Albuquerque, 87106
New Mexico
United States
Clinical Research Alliance
-
Lake Success, 11042
New York
United States
Duke University Medical Center Duke (SC)
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Durham, 27710
North Carolina
United States
Penn State University Milton S Hershey Medical Center
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Hershey, 17033
Pennsylvania
United States
Bon Secours Cancer Center SC
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Greenville, 29607
South Carolina
United States
Erlanger Medical Center SC
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Chattanooga, 37403
Tennessee
United States
Tennessee Oncology Tennessee Oncology (3)
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Nashville, 37203
Tennessee
United States
The Center for Cancer and Blood Disorders SC
-
Fort Worth, 76104
Texas
United States
Methodist Hospital / Methodist Cancer Center Dept of Oncology
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Houston, 77030
Texas
United States
University of Texas MD Anderson Cancer Center SC-5
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Houston, 77030
Texas
United States
Cancer Therapy and Research Center UT Health Science Center SC-4
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San Antonio, 78229
Texas
United States
Brooke Army Medical Center SC
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San Antonio, 78234
Texas
United States
Northern Utah Cancer Associates
-
Ogden, 84403-3105
Utah
United States
Bon Secours Virginia Health System
-
Midlothian, 23114
Virginia
United States
Providence Regional Cancer Partnership
-
Everett, 98201
Washington
United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
-
Kennewick, 99336
Washington
United States
Northwest Medical Specialties Dept of Onc
-
Tacoma, 98405
Washington
United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
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Madison, 53792-6164
Wisconsin
United States
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