Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:June 9, 2015
End Date:February 19, 2020

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A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

This is a multi-center, randomized double-blind, placebo controlled study of ribociclib in
combination with fulvestrant for the treatment of postmenopausal women and men with hormone
receptor positiv e, Her2 negative, advanced breast cancer who have received no or only one
line of endocrine therapy for advanced breast cancer.


Inclusion Criteria:

1. Patient is an adult male/female ≥ 18 years old at the time of informed consent and has
signed informed consent before any trial related activities and according to local
guidelines. Female patients must be postmenopausal.

2. Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer by
local laboratory and has HER2-negative breast cancer.

3. Patient must have either measurable disease by RECIST 1.1 or at least one
predominantly lytic bone lesion.

4. Patient has advanced (loco regionally recurrent not amenable to curative therapy, e.g.
surgery and/or radiotherapy, or metastatic) breast cancer.

Patients may be:

- newly diagnosed advanced/metastatic breast cancer, treatment naïve

- relapsed with documented evidence of relapse more than 12 months from completion
of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic
disease

- relapsed with documented evidence of relapse on or within 12 months from
completion of (neo)adjuvant endocrine therapy with no treatment for
advanced/metastatic disease

- relapsed with documented evidence of relapse more than 12 months from completion
of adjuvant endocrine therapy and then subsequently progressed with documented
evidence of progression after one line of endocrine therapy (with either an
antiestrogen or an aromatase inhibitor) for advanced/metastatic disease

- newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed
with documented evidence of progression after one line of endocrine therapy (with
either an antiestrogen or an aromatase inhibitor)

5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

6. Patient has adequate bone marrow and organ function

Exclusion Criteria:

1. Patient with symptomatic visceral disease or any disease burden that makes the patient
ineligible for endocrine therapy per the investigator's best judgment.

2. Patient has received prior treatment with chemotherapy (except for neoadjuvant/
adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor.

3. Patient with inflammatory breast cancer at screening .

4. Patient with CNS involvement unless they are at least 4 weeks from prior therapy
completion to starting the study treatment and have stable CNS tumor at the time of
screening and not receiving steroids and/or enzyme inducing anti-epileptic medications
for brain metastases

5. Clinically significant, uncontrolled heart disease and/or cardiac repolarization
abnormality

6. Patient is currently receiving any of the following substances and cannot be
discontinued 7 days prior to start the treatment:

- Known strong inducers or inhibitors of CYP3A4/5,

- That have a known risk to prolong the QT interval or induce Torsades de Pointes.

- Those have a narrow therapeutic window and are predominantly metabolized through
CYP3A4/5.

- Herbal preparations/medications, dietary supplements.

Other Protocol-defined Inclusion/Exclusion may apply.
We found this trial at
30
sites
1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Principal Investigator: Ann Stroh
Phone: 970-297-6155
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Albuquerque, New Mexico 87131
Principal Investigator: Melanie Royce
Phone: 505-925-0370
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Bend, Oregon 97701
Principal Investigator: Robert Boone
Phone: 541-706-3732
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Buenos Aires, Caba
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2560 West Chandler Boulevard
Chandler, Arizona 85224
Principal Investigator: Mikhail I. Shtivelband
Phone: 480-855-2234
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Davie, Florida 33328
Principal Investigator: Elizabeth Tan-Chiu
Phone: 954-582-1850
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Fayetteville, Arkansas 72703
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Glens Falls, New York 12801
Principal Investigator: Aqeel A. Gillani
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Hershey, Pennsylvania 17033
Principal Investigator: Cristina Truica
Phone: +1 717 531 0003 x285237
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Honolulu, Hawaii 96817
Principal Investigator: Jennifer Carney
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Houston, Texas 77090
Principal Investigator: Krishna Pachipala
Phone: 832-330-5090
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Jackson, Mississippi 39202
Principal Investigator: Grace G. Shumaker
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Lacey, Washington 98503
Principal Investigator: Fen Jiang
Phone: 360-412-8958
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Lake Success, New York 11042
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Lincoln, Nebraska 68510
Principal Investigator: Steven Dunder
Phone: +1 402 327 7363 ext 131
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Los Angeles, California 90095
Principal Investigator: Dennis Slamon
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Los Angeles, California 90095
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Mobile, Alabama 36608
Principal Investigator: Michael Meshad
Phone: 251-607-5283
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Neptune, New Jersey 07753
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333 East 38th Street
New York, New York 10016
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Ogden, Utah 84403
Principal Investigator: Vincent Hansen
Phone: 801-387-7166
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Orlando, Florida 32804
Principal Investigator: Carlos A. Alemany
Phone: 407-303-3235
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Orlando, Florida 32806
Principal Investigator: Rebecca Moroose
Phone: 321-841-4348
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1700 Luther Lane
Park Ridge, Illinois 60068
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Santa Maria, California 93454
Principal Investigator: Robert Dichmann
Phone: 805-346-3461
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Santa Rosa, California 95403
Principal Investigator: Jarrod P Holmes
Phone: 707-525-3930
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Seattle, Washington 98101
Principal Investigator: Nanette Robinson
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Thomasville, Georgia 31792
Principal Investigator: Teresa Coleman
Phone: 229-584-5468
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Zanesville, Ohio 43701
Principal Investigator: Shyamal Bastola
Phone: 740-586-6618
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