Breast Cancer Clinical Trial
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
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.
Full Description
OBJECTIVES:
Determine the feasibility of 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 in patients with high-risk stage IIIB, IIIC, or IV breast cancer.
Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients undergo stem cell collection.
Course 1: Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®). One day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2.
Course 2: Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation.
After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Eligibility 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
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There is 1 Location for this study
Duarte California, 91010, United States
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