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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 59
Updated:3/16/2019
Start Date:November 20, 2014
End Date:December 21, 2020

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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

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

Other protocol-defined Inclusion/Exclusion may apply.
We found this trial at
43
sites
660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Haeseong Park
Phone: 314-362-0263
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Albuquerque, New Mexico 87106
Principal Investigator: Ursa Brown-Glaberman
Phone: 505-925-0371
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Ann Arbor, Michigan 48109
Principal Investigator: Anne F. Schott
Phone: 734-936-8538
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Bakersfield, California 93309
Principal Investigator: Ravindranath Patel
Phone: 661-616-1619
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Baltimore, Maryland 21231
Principal Investigator: Vered Stearns
Phone: 410-502-3696
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Boston, Massachusetts 02114
Principal Investigator: Aditya Bardia
Phone: 617-643-2208
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Boston, MA
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Chattanooga, Tennessee 37403
Principal Investigator: Rajni Sinha
Phone: 423-778-2982
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Chicago, Illinois 60637
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Cordoba,
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Danbury, Connecticut 06810
Principal Investigator: Michael Cohenuram
Phone: 203-739-6985
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Denver, Colorado 80218
Principal Investigator: Sarah Conlon
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Duarte, California 91010
Principal Investigator: Yuan Yuan
Phone: +1 626 256 4673 64546
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Durham, North Carolina 27710
Principal Investigator: Kimberly Blackwell
Phone: 919-660-1278
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Durham, NC
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Principal Investigator: Peter Jiang
Phone: 425-297-5532
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Fort Myers, Florida 33901
Principal Investigator: Marilyn Raymond
Phone: 561-472-1596
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8931 Colonial Center Drive
Fort Myers, Florida 33901
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Fort Worth, Texas 76104
Principal Investigator: Robyn Ruble Young
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Greenville, South Carolina 29601
Principal Investigator: Stephen Dyar
Phone: 864-603-6211
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Hershey, Pennsylvania 17033
Principal Investigator: Cristina Truica
Phone: 717-531-5777
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1150 North 35th Avenue
Hollywood, Florida 33021
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Honolulu, Hawaii 96817
Principal Investigator: Jennifer Carney
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Houston, Texas 77030
Principal Investigator: Debasish Tripathy
Phone: 713-792-2768
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Houston, Texas 77030
Principal Investigator: Angel Augusto Rodriguez
Phone: +1 713 441 6011
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Houston, Texas 77090
Principal Investigator: Laurent Gressot
Phone: 832-330-5090
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Kansas City, KS
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Kennewick, Washington 99336
Principal Investigator: Rangaswamy Chintapatla
Phone: 509-783-4637
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La Jolla, California 92093
Principal Investigator: Teresa Helsten
Phone: 858-657-7676
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Lake Success, New York 11042
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Los Angeles, California 90095
Principal Investigator: Sara Alsterlind Hurvitz
Phone: +1 310 582 4069
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Louisville, Kentucky 40202
Principal Investigator: Janell Seeger
Phone: 502-629-3673
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Madison, Wisconsin 53792
Principal Investigator: Kari Wisinski
Phone: 608-265-2999
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Marietta, Georgia 30060
Principal Investigator: Raul C. Oyola
Phone: 770-281-5131
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Miami, Florida 33136
Principal Investigator: Reshma Mahtani
Phone: 954-698-3673
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Midlothian, Virginia 23114
Principal Investigator: William Irvin
Phone: 804-894-8665
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Nashville, Tennessee 37203
Principal Investigator: Denise A. Yardley
Phone: 615-329-7664
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Neptune, New Jersey 07754
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Ogden, Utah 84403
Principal Investigator: Vincent Hansen
Phone: 801-387-7406
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Palo Alto, California 94304
Principal Investigator: Suleiman Massarweh
Phone: 650-723-0628
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Pensacola, Florida 32504
Principal Investigator: Tarek Eldawy
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San Antonio, Texas 78229
Principal Investigator: Virginia Kaklamani
Phone: 210-450-1789
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San Antonio, Texas 78234
Principal Investigator: Robert Setlik
Phone: 210-916-0706
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Santa Barbara, California 93110
Principal Investigator: Julie Taguchi
Phone: 805-898-2117
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
Phone: 253-383-3366
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