Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
NCT ID: NCT01528345
Last Updated: 2016-07-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
97 participants
INTERVENTIONAL
2012-04-30
2015-04-30
Brief Summary
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Patients must undergo molecular pre-screening prior to entry.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Fulvestrant + Dovitinib active
Fulvestrant in combination with the study drug Dovitinib.
Dovitinib
Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
Fulvestrant
Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.
Fulvestrant + Dovitinib placebo
Fulvestrant in combination with a placebo matching Dovitinib.
Fulvestrant
Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.
Dovitinib Placebo
Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
Interventions
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Dovitinib
Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
Fulvestrant
Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.
Dovitinib Placebo
Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progression on or after endocrine treatment
* Measureable disease as per RECIST
* ECOG 0, 1 or 2
Exclusion Criteria
* Previous treatment with fulvestrant
* Previous chemotherapy for locally advanced or metastatic breast cancer
* Cirrhosis or chronic active/persistent hepatitis
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States
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
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Córdoba, Córdoba Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Rio Negro, Viedma, Argentina
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Salzburg, , Austria
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Vienna, , Austria
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Leuven, , Belgium
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Wilrijk, , Belgium
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Salvador, Estado de Bahia, Brazil
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Londrina, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Besançon, , France
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Bordeaux, , France
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Lille, , France
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Saint-Herblain Cédex, , France
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Thonon-les-Bains, , France
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Villejuif, , France
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Győr, Hungary, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Macerata, MC, Italy
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Parma, PR, Italy
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Sondrio, SO, Italy
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Surquillo, Lima region, Peru
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Poznan, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Ryazan, Russia, Russia
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Saint Petersburg, , Russia
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Cape Town, , South Africa
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Parktown, , South Africa
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Port Elizabeth, , South Africa
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Toledo, Castille-La Mancha, Spain
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Barcelona, Catalonia, Spain
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Madrid, Madrid, Spain
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Valencia, Valencia, Spain
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Taichung, Taichung, Taiwan
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Niaosong Township, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
Countries
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References
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Musolino A, Campone M, Neven P, Denduluri N, Barrios CH, Cortes J, Blackwell K, Soliman H, Kahan Z, Bonnefoi H, Squires M, Zhang Y, Deudon S, Shi MM, Andre F. Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR+, HER2- breast cancer that had progressed during or after prior endocrine therapy. Breast Cancer Res. 2017 Feb 10;19(1):18. doi: 10.1186/s13058-017-0807-8.
Other Identifiers
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2011-001230-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTKI258A2210
Identifier Type: -
Identifier Source: org_study_id
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