Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:April 2012
End Date:October 2015
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy

This trial is designed to enroll postmenopausal patients with locally advanced or
metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or
radiotherapy, and whose disease has progressed on or after prior endocrine therapy.

Patients must undergo molecular pre-screening prior to entry.


Inclusion Criteria:

1. Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer

2. Progression on or after endocrine treatment

3. Measureable disease as per RECIST

4. ECOG 0, 1 or 2

Exclusion Criteria:

1. Evidence of CNS or leptomeningeal metastases

2. Previous treatment with fulvestrant

3. Previous chemotherapy for locally advanced or metastatic breast cancer

4. Cirrhosis or chronic active/persistent hepatitis

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
29
sites
Lake Success, New York 11042
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Lake Success, NY
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Albuquerque, NM
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Chandler, Arizona 85224
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Chandler, AZ
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Dallas, Texas 75246
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Dallas, TX
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Duarte, CA
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Durham, North Carolina 27710
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Durham, NC
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Fairfax, VA
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Fayetteville, AR
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Goshen, IN
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Greenville, SC
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La Jolla, CA
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Lake Success, New York 11042
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Lake Success, NY
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Laredo, Texas 78041
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Laredo, TX
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Livingston, NJ
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Los Angeles, CA
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Mobile, Alabama 36608
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Mobile, AL
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New Albany, IN
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Omaha, NE
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Park Ridge, IL
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101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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Providence, RI
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Raleigh, North Carolina 27606
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Raleigh, NC
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Roanoke, VA
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San Antonio, TX
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Spokane, Washington 99208
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Spokane, WA
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St. Louis, MO
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Tampa, FL
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Troy, NY
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Washington, North Carolina 27889
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Washington, NC
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Wenatchee, WA
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