Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.

Detailed Description
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OBJECTIVES: To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial. To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy. To summarize the institutional experience of these patients treated with this experimental therapy. OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions). After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.

Official Title
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Accelerated Partial Breast Irradiation

Conditions
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Breast Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Skin Reactions Secondary to Radiation Therapy

Intervention / Treatment
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* Procedure: adjuvant therapy
* Procedure: conventional surgery
* Radiation: 3-dimensional conformal radiation therapy
* Radiation: brachytherapy
* Radiation: intracavitary balloon brachytherapy
* Radiation: proton beam radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Women who have chosen to undergo breast conservation therapy, including lumpectomy and breast irradiation, at the University of Pennsylvania for any invasive mammary carcinoma or intraductal breast cancer Stage I-II invasive or intraductal breast cancer Unifocal tumor ≤ 3.0 cm in size Patients with microscopic multifocality are eligible provided total pathologic tumor size is ≤ 3 cm No proven multicentric carcinoma in more than 1 quadrant or separated by 4 or more centimeters Pre- or post-biopsy ipsilateral* breast MRI negative for multicentric disease (i.e., areas of cancer that cannot be removed in a single excision specimen) or other suspicious findings NOTE: *Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields. Both sides may be treated with partial breast irradiation (PBI) if the pathologic eligibility criteria are met for both tumors, or only one side may be treated with PBI if the criteria are met for only one tumor. Negative margins of excision (≥ 2 mm) OR no tumor seen in a re-excision specimen No extensive intraductal component present Negative sentinel lymph node (SLN) or axillary lymph node dissection OR fewer than 4 positive nodes on adequate axillary lymph node dissection (i.e., 10 or more lymph nodes removed) If a SLN is positive on hematoxylin and eosin (but not by immunohistochemistry alone), complete axillary lymph node dissection is required Axillary lymph node staging is not required for patients with ductal carcinoma in situ No SLN identified in the internal mammary nodes No node > 2 cm No node with extracapsular extension Surgical clips placed in the operative bed OR ability to visualize operative bed on CT scan of the breast Target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on the treatment planning CT scan No diffuse calcifications on diagnostic mammogram Negative post-biopsy mammogram required if presented with mammographically detected microcalcifications Hormone receptor status unspecified PATIENT CHARACTERISTICS: Female Menopausal status not specified History of non-breast malignancies allowed provided patients have been disease free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence Treated carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, or basal cell and squamous cell skin cancer within the past 5 years allowed Patients must agree to undergo breast MRI No contraindication to MRI, including a pacemaker or other foreign body Not pregnant or nursing No technical impediment to appropriate dosimetry No personal history of collagen vascular disease PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior in-field irradiation No presence of breast implant No breast reconstructive surgery prior to study entry No prior neoadjuvant chemotherapy or hormonal therapy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APBI<br> | Procedure: adjuvant therapy<br> <br> Procedure: conventional surgery<br> <br> Radiation: 3-dimensional conformal radiation therapy<br> <br> Radiation: brachytherapy<br> <br> Radiation: intracavitary balloon brachytherapy<br> <br> Radiation: proton beam radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy |  | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up |  | 11 months | 
| Site of disease recurrence (i.e., local, regional, or distant) |  | 11 months | 
| Time to recurrence |  | 11 months | 
| Time to locoregional recurrence |  | 11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-term effects secondary to cancer therapy in adults, skin reactions secondary to radiation therapy, stage I breast cancer, stage II breast cancer, invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, comedo ductal breast carcinoma, ductal breast carcinoma in situ, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, Paget disease of the breast with intraductal carcinoma, Paget disease of the breast with invasive ductal carcinoma, breast cancer in situ