Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells. PURPOSE: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.

Detailed Description
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OBJECTIVES: Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy. Assess the cosmetic results of breast conservation after this treatment in these patients. Determine the pulmonary toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.

Official Title
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Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: paclitaxel
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Stage II or III invasive breast cancer Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required No prior contralateral breast cancer No metastatic disease Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks Candidate for definitive radiotherapy Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT/AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No concurrent poorly controlled ischemic heart disease or congestive heart failure LVEF at least 45% by MUGA scan or echocardiogram Pulmonary: No concurrent severe chronic obstructive or restrictive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent severe medical or psychiatric illness No concurrent severe diabetes mellitus No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) Chemotherapy: See Disease Characteristics Prior tamoxifen allowed No concurrent tamoxifen Endocrine therapy: Not specified Radiotherapy: No prior radiation to the breast Surgery: Recovered form prior surgery Other: No concurrent adjuvant therapy on another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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

| Intervention/Treatment |
| --- |
|Drug: paclitaxel|Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen.|
|Procedure: adjuvant therapy|doxorubicin and cyclophosphamide adjuvant regimen|
|Radiation: radiation therapy|Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the feasibility of concurrent paclitaxel and breast radiotherapy | Ability to deliver appropriate doses of radiation therapy within the appropriate time course | Followed every 3 months for 1 year | 
| chemotherapy dose achieved during concurrent Taxol and radiation therapy. |  | Followed every 3 months for 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor. | These parameters will be assessed by medical and radiation oncology. We expect at least a > 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated. | 1 year | 
| Pulmonary function | Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide). | 1 year | 
| Survival | Patients followed for long term survival for at least 5 years. | 5 years | 

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