Breast Cancer Clinical Trial
Partial Breast Irradiation With Chemotherapy
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain.
PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery.
Full Description
OBJECTIVES:
Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation (PBI) and concurrent cyclophosphamide/doxorubicin (AC) chemotherapy.
Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these patients.
Assess the local control rate in patients treated with this regimen.
OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for approximately 10 years.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast by routine hematoxylin and eosin (H&E) staining
Primary tumor ≤ 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2, pathologic N0-N1, M0)
Patients with lymph nodes positive only by cytokeratin staining (i.e., H&E negative) are eligible
No squamous cell carcinoma or sarcoma of the breast
Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy within the past 14 weeks
Surgical margins at the time of SM must be negative (> 3 mm) for both invasive carcinoma and for non-invasive ductal carcinoma
No active local-regional disease
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Sex: female
Menopausal status not specified
Not pregnant
Negative pregnancy test
Fertile patients must use effective non-hormonal contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No other serious or poorly controlled medical or psychiatric condition that could be exacerbated by, or complicate compliance with study treatment
PRIOR CONCURRENT THERAPY:
No prior radiation therapy to the breast
No prior trastuzumab (Herceptin ®)
No other concurrent chemotherapy
No concurrent hormonal therapy except the following:
Steroids given for adrenal failure
Hormones administered for non-disease-related conditions (e.g., insulin for diabetes, synthroid for hypothyroidism)
Intermittent dexamethasone as an antiemetic or premedication
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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