1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

September 30, 2010

Study Completion Date

November 30, 2012

Conditions
Breast Cancer
Interventions
DRUG

Gemcitabine

Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle

DRUG

Sorafenib

Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

DRUG

Placebo

Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

DRUG

Capecitabine

Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Trial Locations (44)

10065

Memorial Sloan-Kettering Cancer Center, New York

11432

Queens Cancer Center, Jamaica

13057

Hematology Oncology Associates of New York, East Syracuse

14263

Roswell Park Cancer Institute, Buffalo

18512

Hematology Oncology of Northeast Pennsylvania, Dunmore

19106

Pennsylvania Oncology Hematology Associates, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

20010

Washington Cancer Institute, Washington D.C.

28204

Presbyterian Hospital, Charlotte

29403

Charleston Hematology Oncology Associates, Charleston

30060

Northwest Georgia Oncology Center, Marietta

30901

Augusta Oncology Associates, PC, Augusta

31201

Cascade Cancer Center, Macon

Central Georgia Cancer Care, Macon

34613

Pasco Hernando Oncology Associates PA, Brooksville

34652

Pasco Hernando Oncology Associates PA, New Port Richey

38120

The West Clinic, Memphis

44870

North Coast Cancer Care, Sandusky

46601

Northern Indiana Cancer Research Consortium, South Bend

48105

University of Michigan Comprehensive Cancer Center, Ann Arbor

53212

Oncology Alliance, Glendale

60426

Ingalls Memorial Hospital, Harvey

60611

Northwestern University-Robert H. Lurie Comprehensive Cancer Center, Chicago

60612

Rush University Medical Center, Chicago

62301

Quincy Medical Group, Quincy

65109

Columbia Comprehensive Cancer Care Clinic & Research Institute, Jefferson City

70809

Mary Bird Perkins Cancer Center, Baton Rouge

72703

Highlands Oncology Group, Fayetteville

80528

Front Range Cancer Specialists, Fort Collins

90806

Long Beach Memorial Medical Center, Long Beach

92501

Compassionate Cancer Care-Riverside, Riverside

92879

Compassionate Cancer Care-Corona, Corona

Compassionate Cancer Care-Fountain Valley, Fountain Valley

94107

California Pacific Medical Center, San Francisco

94115

University of California San Francisco Comprehensive Cancer Center, San Francisco

98516

Sutter Cancer Center, Sacramento

99508

Providence Cancer Center / Katmai Oncology Group LLC, Anchorage

94904-2007

California Cancer Care, Greenbrae

06902

Hematology Oncology PC / Bennett Cancer Center, Stamford

06611

Oncology Associates of Bridgeport, Trumbull

04474-9308

Maine Center for Cancer Medicine, Scarborough

02118

Boston Medical Center, Boston

01107

Baystate Medical Center, Springfield

07134

Oncology Hematology Specialists, PA, Denville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Accelerated Community Oncology Research Network

OTHER

NCT00493636 - 1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy | Biotech Hunter | Biotech Hunter