Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

July 31, 2009

Study Completion Date

October 31, 2012

Conditions
Breast Cancer
Interventions
DRUG

Docetaxel

"Sequential Therapy: Docetaxel will be given at 100 mg/m\^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles.~Concurrent Therapy: Docetaxel will be given at 50 mg/m\^2 IV Day 1."

DRUG

Capecitabine

Sequential Therapy: administration of capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Trial Locations (19)

30045

Suburban Hematology-Oncology Associates, PC, Lawrenceville

30060

WellStar Health System-Georgia Cancer Specialists, Marietta

WellStar Health System-Northwest Georgia Oncology Center, PC, Marietta

30078

Suburban Hematology-Oncology Associates, PC, Snellville

30096

Suburban Hematology-Oncology Associates, PC, Duluth

30106

WellStar Health System-Georgia Cancer Specialists, Austell

WellStar Health System-Northwest Georgia Oncology Center, PC, Austell

30117

WellStar Health System-Northwest Georgia Oncology Center, PC, Carrollton

30274

South Atlanta Hematology-Oncology Group, Riverdale

30281

South Atlanta Hematology-Oncology Group, Stockbridge

30303

Grady Memorial Hospital, Atlanta

30308

Emory Crawford Long Hospital, Atlanta

30322

Emory University Winship Cancer Institute, Atlanta

30344

South Atlanta Hematology-Oncology Group, East Point

30901

Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300, Augusta

30909

Augusta Oncology Associates, PC 3696 Wheeler Road, Augusta

31093

Central Georgia Cancer Care, PC, Warner Robins

31201

Central Georgia Cancer Care, PC, Macon

31904

John B. Amos Cancer Center, Columbus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Georgia Center for Oncology Research & Education

OTHER

collaborator

Sanofi

INDUSTRY

lead

Emory University

OTHER

NCT00209092 - Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer | Biotech Hunter | Biotech Hunter