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
18 Years
N/A
Female
Metastatic Breast Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS)
Outcome Description:
PFS is defined as the date of randomization to the date of the first radiologically documented disease progression (PD) or death due to any cause per local investigator assessment as per RECIST.
Outcome Time Frame:
Every 8 weeks assessed up to 24 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CTKI258A2210
NCT ID:
NCT01528345
Start Date:
April 2012
Completion Date:
October 2014
Related Keywords:
- Metastatic Breast Cancer
- Breast Cancer
- HER2-, HR+
- post-menopausal
- Locally advanced or metastatic Breast Cancer (HER2-, HR+)
- Breast Neoplasms
Name | Location |
|---|---|
| Raleigh Hematology Oncology Clinic | Cary, North Carolina 27511 |
| Women and Infants Hospital | Providence, Rhode Island 02905 |
| Marion L. Shepard Cancer Center | Washington, North Carolina |
| US Oncology Central Monitoring | Dallas, Texas 75246 |
| Ironwood Cancer and Research Centers Ironwood | Chandler, Arizona 85224 |
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville, Arkansas 72703 |
| New York Oncology Hematology, P.C. Dept. of New York Oncology. PC | Troy, New York 12180 |
| Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) | San Antonio, Texas 78229 |
| Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care | Roanoke, Virginia 24014 |
| Cancer Centers of the Carolinas Dept. of CC of the Carolinas | Greenville, South Carolina 29605 |
| City of Hope National Medical Center COH 3 | Duarte, California 91010-3000 |
| University of California San Diego SC-1 | La Jolla, California 92093-0658 |
| Cedars Sinai Medical Center Samuel Oschin Cancer Center | Los Angeles, California 90048 |
| H. Lee Moffitt Cancer Center/University of South Florida H. Lee Moffitt SC | Tampa, Florida 33612 |
| Oncology Specialists, SC Lutheran General Advanced Care | Park Ridge, Illinois 60068-0736 |
| Floyd Memorial Cancer Center of Indiana Floyd Memorial | New Albany, Indiana 47150 |
| Washington University School Of Medicine-Siteman Cancer Ctr Was Univ School of Med | St. Louis, Missouri 63110 |
| Methodist Cancer Center Methodist Estabrook | Omaha, Nebraska 68114 |
| Saint Barnabas Medical Center CancerCenter of Saint Barnabas | Livingston, New Jersey 07039 |
| University of New Mexico Hospital Univ NM Hosp | Albuquerque, New Mexico 87106 |
| ProHealth Care | Lake Success, New York 11042 |
| Duke University Medical Center Duke (SC) | Durham, North Carolina 27710 |
| Fairfax Northern Virginia Hematology Oncology Dept.ofFairfax SC | Fairfax, Virginia 22031 |
| Wenatchee Valley Medical Center Wenatchee Valley | Wenatchee, Washington 98801 |
| Southern Cancer Center PC SC | Mobile, Alabama 36608 |
