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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01528345
First received: January 31, 2012
Last updated: June 19, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Dovitinib
Drug: Fulvestrant
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Every 8 weeks assessed up to 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Every 8 weeks assessed up to 24 months ] [ Designated as safety issue: No ]
    ORR is defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST

  • Duration of Response (DOR) [ Time Frame: From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) [ Time Frame: From date of randomization to date of death from any cause whichever comes first, assessed up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Safety (type, frequency and severity of adverse events, and laboratory values) [ Time Frame: Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 6-9 months) ] [ Designated as safety issue: Yes ]
    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

  • 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.) [ Time Frame: Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months) ] [ Designated as safety issue: No ]
    The time to worsening of ECOG performance status will be measured.


Enrollment: 97
Study Start Date: April 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fulvestrant + Dovitinib active
Fulvestrant in combination with the study drug Dovitinib. 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. In addition, 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 Dovitinib on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").
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").
Placebo Comparator: Fulvestrant + Dovitinib placebo
Fulvestrant in combination with a placebo matching Dovitinib. 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. Placebo 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 placebo Dovitinib on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528345

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States, 85224
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, California
City of Hope National Medical Center COH 3
Duarte, California, United States, 91010-3000
University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1
La Jolla, California, United States, 92093-0658
Cedars Sinai Medical Center Samuel Oschin Cancer Center
Los Angeles, California, United States, 90048
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC
Tampa, Florida, United States, 33612
United States, Illinois
Oncology Specialists, SC Lutheran General Advanced Care
Park Ridge, Illinois, United States, 60068-0736
United States, Indiana
Indiana University Health Goshen Center for Cancer SC
Goshen, Indiana, United States, 46526
United States, Nebraska
Nebraska Methodist Hospital Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Jersey
Saint Barnabas Medical Center CancerCenter of Saint Barnabas
Livingston, New Jersey, United States, 07039
United States, New York
ProHealth Care
Lake Success, New York, United States, 11042
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
Troy, New York, United States, 12180
United States, North Carolina
Duke University Medical Center Duke (SC)
Durham, North Carolina, United States, 27710
United States, South Carolina
Cancer Centers of the Carolinas Dept. of CC of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Specialists, PC Dept.ofFairfax SC
Fairfax, Virginia, United States, 22031
United States, Washington
Medical Oncology Associates, PS
Spokane, Washington, United States, 99208
Wenatchee Valley Medical Center Wenatchee Valley
Wenatchee, Washington, United States, 98801
Argentina
Novartis Investigative Site
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site
Buenos Aires, Argentina, C1050AAK
Novartis Investigative Site
Cordoba, Argentina, X5006IKK
Novartis Investigative Site
Tucuman, Argentina, T4000IAK
Austria
Novartis Investigative Site
Salzburg, Austria, 5020
Novartis Investigative Site
Wien, Austria, 1090
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Wilrijk, Belgium, 2610
Brazil
Novartis Investigative Site
Salvador, BA, Brazil, 40170-110
Novartis Investigative Site
Londrina, PR, Brazil, 86015-520
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Novartis Investigative Site
São Paulo, SP, Brazil, 01317-002
France
Novartis Investigative Site
Besançon cedex, France, 25030
Novartis Investigative Site
Bordeaux, France, 33076
Novartis Investigative Site
Lille Cedex, France, 59020
Novartis Investigative Site
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site
Thonon-les-Bains Cedex, France, 74203
Novartis Investigative Site
Villejuif Cedex, France, 94805
Hungary
Novartis Investigative Site
Budapest, Hungary, 1134
Novartis Investigative Site
Budapest, Hungary, H-1083
Novartis Investigative Site
Budapest, Hungary, 1145
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Gyor, Hungary, H-9023
Novartis Investigative Site
Szeged, Hungary, H-6720
Novartis Investigative Site
Szolnok, Hungary, H-5000
Italy
Novartis Investigative Site
Macerata, MC, Italy, 62100
Novartis Investigative Site
Parma, PR, Italy, 43100
Novartis Investigative Site
Sondrio, SO, Italy, 23100
Netherlands
Novartis Investigative Site
Maastricht, Netherlands, 6229 HX
Novartis Investigative Site
Rotterdam, Netherlands, 3075 EA
Peru
Novartis Investigative Site
Surquillo, Lima, Peru, 34
Poland
Novartis Investigative Site
Poznan, Poland, 60-569
Novartis Investigative Site
Rzeszow, Poland, 35-021
Novartis Investigative Site
Warszawa, Poland, 02-781
Novartis Investigative Site
Warszawa, Poland, 03-291
Novartis Investigative Site
Warszawa, Poland, 04-125
Russian Federation
Novartis Investigative Site
Ryazan, Russia, Russian Federation, 390011
Novartis Investigative Site
St. Petersburg, Russian Federation, 197758
South Africa
Novartis Investigative Site
Cape Town, South Africa, 7500
Novartis Investigative Site
Parktown, South Africa, 2193
Novartis Investigative Site
Port Elizabeth, South Africa, 6045
Spain
Novartis Investigative Site
Toledo, Castilla la Mancha, Spain, 45004
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site
Madrid, Spain, 28007
Taiwan
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Novartis Investigative Site
Taichung, Taiwan, 407
Novartis Investigative Site
Taipei, Taiwan, 10048
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01528345     History of Changes
Other Study ID Numbers: CTKI258A2210, 2011-001230-42
Study First Received: January 31, 2012
Last Updated: June 19, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Egypt: Ministry of Health and Population
France: Agence française de sécurité sanitaire des produits de santé (Afssaps)
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Italian Pharmaceutical Agency (AIFA)
Netherlands: Medicines Evaluation Board (MEB)
Peru: National Health Institute
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Africa: Department of Health
Spain: Medicines and Health Products Agency (AEMPS)
Taiwan: Department of Health

Keywords provided by Novartis:
Breast Cancer
HER2-, HR+
post-menopausal
Locally advanced or metastatic Breast Cancer (HER2-, HR+)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Estradiol
Fulvestrant
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2015