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 |
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.
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
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101 Dudley St
Providence, Rhode Island 02905
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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Roanoke, Virginia 24014
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