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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Melphalan; Thiotepa; Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer, meeting 1 of the following stage criteria:

• Stage IIIB or IIIC disease, meeting both of the following criteria:

• Must have received prior neoadjuvant or adjuvant therapy

• Must have undergone lumpectomy or mastectomy

• Stage IV disease, meeting all of the following criteria:

• Only 1-3 organ sites with disease involvement after induction chemotherapy

• Achieved at least a partial response after induction chemotherapy

• No more than 3 lesions in the organ sites combined

• Inflammatory breast cancer allowed

• Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6 months

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 65 and under

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• SGOT or SGPT ≤ 2 times upper limit of normal

• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine ≤ 1.2 mg/dL

• Creatinine clearance ≥ 70 mL/min

Cardiovascular

• LVEF ≥ 55% by MUGA or echocardiogram

Pulmonary

• FEV_1 ≥ 60% of predicted

• DLCO ≥ 60% of the lower limit of predicted value

• Oxygen saturation > 92% on room air

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No autoimmune disorders

• No immunosuppressive condition

• No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy except trastuzumab (Herceptin®)

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy to adjacent or involved sites of disease that would preclude study radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent anticancer therapy