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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528345
• Other study ID #: CTKI258A2210
• Secondary ID: 2011-001230-42
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2012
• Last updated: June 19, 2015
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of HealthAustria: Federal Ministry for Health and WomenBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: Ministry of HealthEgypt: Ministry of Health and PopulationFrance: Agence française de sécurité sanitaire des produits de santé (Afssaps)Hungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: Italian Pharmaceutical Agency (AIFA)Netherlands: Medicines Evaluation Board (MEB)Peru: National Health InstitutePoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSouth Africa: Department of HealthSpain: Medicines and Health Products Agency (AEMPS)Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Dovitinib
Active Dovitinib (in tablet form) will be taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule (i.e patients will take active Dovitinib on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").
• Fulvestrant
Fulvestrant (in solution) will be 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.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Rio Negro	Viedma
Argentina	Novartis Investigative Site	Tucuman
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Wilrijk
Brazil	Novartis Investigative Site	Londrina	PR
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	Sao Jose do Rio Preto	SP
Brazil	Novartis Investigative Site	São Paulo	SP
France	Novartis Investigative Site	Besançon cedex
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Saint-Herblain Cédex
France	Novartis Investigative Site	Thonon-les-Bains Cedex
France	Novartis Investigative Site	Villejuif Cedex
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Gyor
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szolnok
Italy	Novartis Investigative Site	Macerata	MC
Italy	Novartis Investigative Site	Parma	PR
Italy	Novartis Investigative Site	Sondrio	SO
Netherlands	Novartis Investigative Site	Maastricht
Netherlands	Novartis Investigative Site	Rotterdam
Peru	Novartis Investigative Site	Surquillo	Lima
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Rzeszow
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Russian Federation	Novartis Investigative Site	Ryazan	Russia
Russian Federation	Novartis Investigative Site	St. Petersburg
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Parktown
South Africa	Novartis Investigative Site	Port Elizabeth
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Toledo	Castilla la Mancha
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Taiwan	Novartis Investigative Site	Niaosong Township
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
United States	Ironwood Cancer and Research Centers SC	Chandler	Arizona
United States	City of Hope National Medical Center COH 3	Duarte	California
United States	Duke University Medical Center Duke (SC)	Durham	North Carolina
United States	Virginia Cancer Specialists, PC Dept.ofFairfax SC	Fairfax	Virginia
United States	Highlands Oncology Group Dept of Highlands Oncology Grp	Fayetteville	Arkansas
United States	Indiana University Health Goshen Center for Cancer SC	Goshen	Indiana
United States	Cancer Centers of the Carolinas Dept. of CC of the Carolinas	Greenville	South Carolina
United States	University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1	La Jolla	California
United States	ProHealth Care	Lake Success	New York
United States	Saint Barnabas Medical Center CancerCenter of Saint Barnabas	Livingston	New Jersey
United States	Cedars Sinai Medical Center Samuel Oschin Cancer Center	Los Angeles	California
United States	Nebraska Methodist Hospital Estabrook Cancer Center	Omaha	Nebraska
United States	Oncology Specialists, SC Lutheran General Advanced Care	Park Ridge	Illinois
United States	Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)	San Antonio	Texas
United States	Medical Oncology Associates, PS	Spokane	Washington
United States	H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC	Tampa	Florida
United States	New York Oncology Hematology, P.C. Dept. of New York Oncology. PC	Troy	New York
United States	Wenatchee Valley Medical Center Wenatchee Valley	Wenatchee	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  France,  Hungary,  Italy,  Netherlands,  Peru,  Poland,  Russian Federation,  South Africa,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	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.	Every 8 weeks assessed up to 24 months	No
Secondary	Overall Response Rate (ORR)	ORR is defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST	Every 8 weeks assessed up to 24 months	No
Secondary	Duration of Response (DOR)	DOR is defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment.	From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months	No
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.	From date of randomization to date of death from any cause whichever comes first, assessed up to 24 months	No
Secondary	Safety (type, frequency and severity of adverse events, and laboratory values)	The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events	Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 6-9 months)	Yes
Secondary	Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.)	The time to worsening of ECOG performance status will be measured.	Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)	No