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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

Every 8 weeks assessed up to 24 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2210

NCT ID:

NCT01528345

Start Date:

April 2012

Completion Date:

October 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • HER2-, HR+
  • post-menopausal
  • Locally advanced or metastatic Breast Cancer (HER2-, HR+)
  • Breast Neoplasms

Name

Location

Raleigh Hematology Oncology ClinicCary, North Carolina  27511
Women and Infants HospitalProvidence, Rhode Island  02905
Marion L. Shepard Cancer CenterWashington, North Carolina  
US Oncology Central MonitoringDallas, Texas  75246
Ironwood Cancer and Research Centers IronwoodChandler, Arizona  85224
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
New York Oncology Hematology, P.C. Dept. of New York Oncology. PCTroy, New York  12180
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)San Antonio, Texas  78229
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer CareRoanoke, Virginia  24014
Cancer Centers of the Carolinas Dept. of CC of the CarolinasGreenville, South Carolina  29605
City of Hope National Medical Center COH 3Duarte, California  91010-3000
University of California San Diego SC-1La Jolla, California  92093-0658
Cedars Sinai Medical Center Samuel Oschin Cancer CenterLos Angeles, California  90048
H. Lee Moffitt Cancer Center/University of South Florida H. Lee Moffitt SCTampa, Florida  33612
Oncology Specialists, SC Lutheran General Advanced CarePark Ridge, Illinois  60068-0736
Floyd Memorial Cancer Center of Indiana Floyd MemorialNew Albany, Indiana  47150
Washington University School Of Medicine-Siteman Cancer Ctr Was Univ School of MedSt. Louis, Missouri  63110
Methodist Cancer Center Methodist EstabrookOmaha, Nebraska  68114
Saint Barnabas Medical Center CancerCenter of Saint BarnabasLivingston, New Jersey  07039
University of New Mexico Hospital Univ NM HospAlbuquerque, New Mexico  87106
ProHealth CareLake Success, New York  11042
Duke University Medical Center Duke (SC)Durham, North Carolina  27710
Fairfax Northern Virginia Hematology Oncology Dept.ofFairfax SCFairfax, Virginia  22031
Wenatchee Valley Medical Center Wenatchee ValleyWenatchee, Washington  98801
Southern Cancer Center PC SCMobile, Alabama  36608