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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT01528345

Run by

Novartis Pharmaceuticals

People needed

97

Starts

2012-04-01

Expected to finish

2015-04-01

Last updated by the study team

2016-07-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer
• Progression on or after endocrine treatment
• Measureable disease as per RECIST
• ECOG 0, 1 or 2

You may not qualify if…

• Evidence of CNS or leptomeningeal metastases
• Previous treatment with fulvestrant
• Previous chemotherapy for locally advanced or metastatic breast cancer
• Cirrhosis or chronic active/persistent hepatitis
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States
• City of Hope National Medical Center COH 3 — Duarte, California, United States
• University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1 — La Jolla, California, United States
• Cedars Sinai Medical Center Samuel Oschin Cancer Center — Los Angeles, California, United States
• H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC — Tampa, Florida, United States
• Oncology Specialists, SC Lutheran General Advanced Care — Park Ridge, Illinois, United States
• Indiana University Health Goshen Center for Cancer SC — Goshen, Indiana, United States
• Nebraska Methodist Hospital Estabrook Cancer Center — Omaha, Nebraska, United States
• Saint Barnabas Medical Center CancerCenter of Saint Barnabas — Livingston, New Jersey, United States
• ProHealth Care — Lake Success, New York, United States
• New York Oncology Hematology, P.C. Dept. of New York Oncology. PC — Troy, New York, United States
• Duke University Medical Center Duke (SC) — Durham, North Carolina, United States
• Cancer Centers of the Carolinas Dept. of CC of the Carolinas — Greenville, South Carolina, United States
• Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) — San Antonio, Texas, United States
• Virginia Cancer Specialists, PC Dept.ofFairfax SC — Fairfax, Virginia, United States
• Medical Oncology Associates, PS — Spokane, Washington, United States
• Wenatchee Valley Medical Center Wenatchee Valley — Wenatchee, Washington, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — Rio Negro, Viedma, Argentina
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Leuven, Belgium
• Ironwood Cancer and Research Centers SC — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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