Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Breast Cancer
Interventions
BIOLOGICAL

trastuzumab

Cycle 1: 6 mg/kg on day -2 from PBSC reinfusion Cycle 2: 6 mg/kg on day -7 from PBSC reinfusion

DRUG

carboplatin

Cycle 2: 800 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

DRUG

cyclophosphamide

Cycle 2: 6000 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

DRUG

melphalan

Cycle 1: 150 mg/m2 on day -1 from PBSC reinfusion

DRUG

thiotepa

Cycle 2: 500 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

PROCEDURE

adjuvant therapy

Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy.

PROCEDURE

autologous-autologous tandem hematopoietic stem cell transplantation

Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation.

PROCEDURE

bone marrow ablation with stem cell support

Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation

RADIATION

radiation therapy

"After recovery from high-dose chemotherapy and autologous PBSC transplantation; patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Treatment should be delivered daily M-F @ 180-200 cGY/day to a total of 4,500 to 5,040 cGy.~Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. Treatment should be delivered daily @180-220 cGY/day to a total of 4,000-5,000 cGy."

Trial Locations (1)

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER

NCT00182793 - Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer | Biotech Hunter | Biotech Hunter