Clinical trial NCT01528345: Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer
HER2-, HR+
post-menopausal
Locally advanced or metastatic Breast Cancer (HER2-, HR+)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression Free Survival (PFS) Based on Local Investigator Assessment
timeFrame: Every 8 weeks assessed up to 34 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Every 8 weeks assessed up to 34 months
measure: Duration of Response (DOR)
timeFrame: From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months
measure: Overall Survival (OS) Using Kaplan- Meier Method
timeFrame: From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months
measure: Number of Participants With Adverse Events as a Measure of Safety
timeFrame: Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months)
measure: Time to Worsening of ECOG Performance Status
timeFrame: Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers SC
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group Dept of Highlands Oncology Grp
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center COH 3
state: California
city: La Jolla
country: United States
facility: University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Samuel Oschin Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists, SC Lutheran General Advanced Care
state: Illinois
city: Goshen
country: United States
facility: Indiana University Health Goshen Center for Cancer SC
state: Indiana
city: Omaha
country: United States
facility: Nebraska Methodist Hospital Estabrook Cancer Center
state: Nebraska
city: Livingston
country: United States
facility: Saint Barnabas Medical Center CancerCenter of Saint Barnabas
state: New Jersey
city: Lake Success
country: United States
facility: ProHealth Care
state: New York
city: Troy
country: United States
facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Duke (SC)
state: North Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas Dept. of CC of the Carolinas
state: South Carolina
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC Dept.ofFairfax SC
state: Virginia
city: Spokane
country: United States
facility: Medical Oncology Associates, PS
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center Wenatchee Valley
state: Washington
city: Rio Negro
country: Argentina
facility: Novartis Investigative Site
state: Viedma
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Tucuman
country: Argentina
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: BA
city: Londrina
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Sao Jose do Rio Preto
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Besançon cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Saint-Herblain Cédex
country: France
facility: Novartis Investigative Site
city: Thonon-les-Bains Cedex
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szolnok
country: Hungary
facility: Novartis Investigative Site
city: Macerata
country: Italy
facility: Novartis Investigative Site
state: MC
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Sondrio
country: Italy
facility: Novartis Investigative Site
state: SO
city: Maastricht
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Surquillo
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Parktown
country: South Africa
facility: Novartis Investigative Site
city: Port Elizabeth
country: South Africa
facility: Novartis Investigative Site
city: Toledo
country: Spain
facility: Novartis Investigative Site
state: Castilla la Mancha
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Niaosong Township
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.