Partial Breast Irradiation With Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: cyclophosphamide
* Drug: Doxorubicin
* Radiation: radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBI with Concurrent Chemotherapy<br>Phase I Single Arm study of PBI with concurrent chemotherapy. Primary endpoint is radiation toxicity. The intervention is partial breast radiation with doxorubicin and cyclophosphamide. | Drug: cyclophosphamide<br>* chemotherapy<br>* Other names: adriamycin;Drug: Doxorubicin<br>* doxorubicin<br>* Other names: cytoxan;Radiation: radiation<br>* radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity | Number of participants with Grade 4 toxicity as defined by the following criteria: Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= Necrosis | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer