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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01528345
First received: January 31, 2012
Last updated: March 20, 2014
Last verified: March 2014
  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.


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Alabama
Southern Cancer Center PC SC Withdrawn
Mobile, Alabama, United States, 36608
United States, Arizona
Ironwood Cancer and Research Centers SC Recruiting
Chandler, Arizona, United States, 85224
Contact: Bobbi-Jo Campbell       bcampbell@ironwoodcrc.com   
Principal Investigator: Mikhail Shtivelband         
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Amanda Nickel    +1 479 872 8130    anickel@hogonc.com   
Principal Investigator: Joseph Thaddeus Beck         
United States, California
City of Hope National Medical Center COH 3 Recruiting
Duarte, California, United States, 91010-3000
Contact: Katrina Gomez    626-471-9200    kgomez@coh.org   
Principal Investigator: Thehang Luu         
University of California San Diego Moores UCSD Cancer Ctr. SC-1 Recruiting
La Jolla, California, United States, 92093-0658
Contact: Suzanne Freidrich    858-822-7973    sfriedrich@ucsd.edu   
Principal Investigator: Teresa Helsten         
Cedars Sinai Medical Center Samuel Oschin Cancer Center Recruiting
Los Angeles, California, United States, 90048
Contact: Kathryn P. Componeschi    310-967-4335    kathryn.componeschi@cshs.org   
Principal Investigator: William Audeh         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC Recruiting
Tampa, Florida, United States, 33612
Contact: Gina Barry    813-745-1807    gina.barry@moffitt.org   
Principal Investigator: Hatem Soliman         
United States, Illinois
Oncology Specialists, SC Lutheran General Advanced Care Recruiting
Park Ridge, Illinois, United States, 60068-0736
Contact: Dilnaz Hassan    847-418-0659    dhassan@oncmed.net   
Principal Investigator: Sigrun Hallmeyer         
United States, Indiana
Indiana University Health Goshen Center for Cancer SC Recruiting
Goshen, Indiana, United States, 46526
Contact: Jamie Douthitt    574-364-2974    jddouthi@iupui.edu   
Principal Investigator: Daniel Bruetman         
Floyd Memorial Cancer Center of Indiana Floyd Memorial Withdrawn
New Albany, Indiana, United States, 47150
United States, Missouri
Washington University School Of Medicine-Siteman Cancer Ctr Was Univ School of Med Withdrawn
St. Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Methodist Hospital Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Sherry Thorne    +1 402 354 8250    sherry.thorne@nmhs.org   
Principal Investigator: Margaret Barbara Block         
United States, New Jersey
Saint Barnabas Medical Center CancerCenter of Saint Barnabas Recruiting
Livingston, New Jersey, United States, 07039
Contact: Elyce Hirtler    973-322-2470    ehirtler@barnabashealth.org   
Principal Investigator: Richard A. Michaelson         
United States, New Mexico
University of New Mexico Hospital Univ NM Hosp Withdrawn
Albuquerque, New Mexico, United States, 87106
United States, New York
ProHealth Care Recruiting
Lake Success, New York, United States, 11042
Contact: Eileen Stiene    516-622-6150    estiene@prohealthcare.com   
Principal Investigator: Marc Citron         
Clinical Research Alliance Not yet recruiting
Lake Success, New York, United States, 11042
Contact: Victoria Travers    855-737-2873 x183    vtravers@researchcra.com   
Principal Investigator: Morton Coleman         
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC Recruiting
Troy, New York, United States, 12180
Contact: Yolenny Vargas    518-489-4030    yolenny.vargas@usonocology.com   
Principal Investigator: Regina Resta         
United States, North Carolina
Duke University Medical Center Duke (SC) Recruiting
Durham, North Carolina, United States, 27710
Contact: Delinda Phillips    919-660-1278    delinda.phillips@duke.edu   
Principal Investigator: Kimberly Blackwell         
Raleigh Hematology Oncology Clinic Withdrawn
Raleigh, North Carolina, United States, 27606
Marion L. Shepard Cancer Center Withdrawn
Washington, North Carolina, United States, 27889
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Teddy Santos    401-453-7520    tsantos@wilhri.org   
Principal Investigator: Bachir Sakr         
United States, South Carolina
Cancer Centers of the Carolinas Dept. of CC of the Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: Alexis Kelly    +1 864 242 2762    alexis.kelly@usoncology.com   
Principal Investigator: William Jeffery Edenfield         
United States, Texas
US Oncology Central Monitoring Withdrawn
Dallas, Texas, United States, 75246
Institute of Oncology Hematology Not yet recruiting
Laredo, Texas, United States, 78041
Contact: Noe Garcia    956-753-7839    ngarcia@stexresearch.com   
Principal Investigator: Eduardo Miranda         
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) Completed
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Specialists, PC Dept.ofFairfax SC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Sonja Crandon    703-208-5390    sonja.crandon@usoncology.com   
Principal Investigator: Neelima Denduluri         
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care Withdrawn
Roanoke, Virginia, United States, 24014
United States, Washington
Medical Oncology Associates, PS Not yet recruiting
Spokane, Washington, United States, 99208
Contact: Monika Chaudhry    509-462-2273    chaudhrym@mwrm.com   
Principal Investigator: Arvind Chaudhry         
Wenatchee Valley Medical Center Wenatchee Valley Recruiting
Wenatchee, Washington, United States, 98801
Contact: Lori VanLith    +1 509 665 5800 5122    lvanlith@wvmedical.com   
Principal Investigator: Mitchell Garrison         
Argentina
Novartis Investigative Site Recruiting
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1050AAK
Novartis Investigative Site Recruiting
Cordoba, Argentina, X5006IKK
Novartis Investigative Site Recruiting
Tucuman, Argentina, T4000IAK
Austria
Novartis Investigative Site Recruiting
Salzburg, Austria, 5020
Novartis Investigative Site Recruiting
Wien, Austria, 1090
Belgium
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Recruiting
Wilrijk, Belgium, 2610
Brazil
Novartis Investigative Site Not yet recruiting
Salvador, BA, Brazil, 40170-110
Novartis Investigative Site Not yet recruiting
Recife, PE, Brazil, 50070-550
Novartis Investigative Site Recruiting
Londrina, PR, Brazil, 86015-520
Novartis Investigative Site Not yet recruiting
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site Not yet recruiting
Itajai, SC, Brazil, 88301-229
Novartis Investigative Site Not yet recruiting
Campinas, SP, Brazil, 13083-970
Novartis Investigative Site Not yet recruiting
Jaú, SP, Brazil, 17210-080
Novartis Investigative Site Not yet recruiting
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Novartis Investigative Site Not yet recruiting
São Paulo, SP, Brazil, 01317-002
Egypt
Novartis Investigative Site Withdrawn
Cairo, Egypt
Novartis Investigative Site Withdrawn
Menoufiya, Egypt
France
Novartis Investigative Site Recruiting
Besançon cedex, France, 25030
Novartis Investigative Site Recruiting
Bordeaux, France, 33076
Novartis Investigative Site Recruiting
Lille Cedex, France, 59020
Novartis Investigative Site Withdrawn
Lyon Cedex, France, 69373
Novartis Investigative Site Recruiting
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site Recruiting
Thonon-les-Bains Cedex, France, 74203
Novartis Investigative Site Withdrawn
Toulouse Cedex 3, France, 31052
Novartis Investigative Site Recruiting
Villejuif Cedex, France, 94805
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, H-1083
Novartis Investigative Site Recruiting
Budapest, Hungary, 1145
Novartis Investigative Site Recruiting
Budapest, Hungary, 1134
Novartis Investigative Site Recruiting
Debrecen, Hungary, 4032
Novartis Investigative Site Recruiting
Gyor, Hungary, H-9023
Novartis Investigative Site Recruiting
Szeged, Hungary, H-6720
Novartis Investigative Site Recruiting
Szolnok, Hungary, H-5000
Italy
Novartis Investigative Site Recruiting
Macerata, MC, Italy, 62100
Novartis Investigative Site Recruiting
Parma, PR, Italy, 43100
Novartis Investigative Site Recruiting
Sondrio, SO, Italy, 23100
Netherlands
Novartis Investigative Site Recruiting
Maastricht, Netherlands, 6229 HX
Novartis Investigative Site Recruiting
Rotterdam, Netherlands, 3075 EA
Peru
Novartis Investigative Site Recruiting
Surquillo, Lima, Peru, 34
Novartis Investigative Site Withdrawn
Lima, Peru
Poland
Novartis Investigative Site Withdrawn
Bydgoszcz, Poland, 85-796
Novartis Investigative Site Not yet recruiting
Kraków, Poland, 31-115
Novartis Investigative Site Recruiting
Poznan, Poland, 60-569
Novartis Investigative Site Withdrawn
Poznan, Poland, 01-866
Novartis Investigative Site Recruiting
Rzeszow, Poland, 35922
Novartis Investigative Site Not yet recruiting
Warszawa, Poland, 03-291
Novartis Investigative Site Not yet recruiting
Warszawa, Poland, 04-125
Novartis Investigative Site Withdrawn
Warszawa, Poland, 04-125
Novartis Investigative Site Not yet recruiting
Warszawa, Poland, 02-781
Russian Federation
Novartis Investigative Site Recruiting
Ryazan, Russia, Russian Federation, 390011
Novartis Investigative Site Not yet recruiting
St-Petersburg, Russia, Russian Federation, 1970022
Novartis Investigative Site Withdrawn
Moscow, Russian Federation, 115478
Novartis Investigative Site Recruiting
St. Petersburg, Russian Federation, 197758
South Africa
Novartis Investigative Site Recruiting
Cape Town, South Africa, 7500
Novartis Investigative Site Recruiting
Parktown, South Africa, 2193
Novartis Investigative Site Recruiting
Port Elizabeth, South Africa, 6045
Novartis Investigative Site Recruiting
Pretoria, South Africa, 0002
Spain
Novartis Investigative Site Recruiting
Toledo, Castilla la Mancha, Spain, 45004
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Terminated
Madrid, Spain, 28009
Taiwan
Novartis Investigative Site Recruiting
Niaosong Township, Taiwan, 83301
Novartis Investigative Site Recruiting
Taichung, Taiwan, 407
Novartis Investigative Site Recruiting
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: March 20, 2014
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens
Hormones

ClinicalTrials.gov processed this record on August 28, 2014