Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

Study Overview
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Brief Summary
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This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.

Detailed Description
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PRIMARY OBJECTIVE: I. For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose. SECONDARY OBJECTIVE: I. Locoregional control reported at five years. OUTLINE: Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then every 6 months for 2 years.

Official Title
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Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer

Conditions
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Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Invasive Cribriform Breast Carcinoma, Invasive Ductal Carcinoma, Not Otherwise Specified, Lobular Breast Carcinoma In Situ, Mucinous Breast Carcinoma, Papillary Breast Carcinoma, Progesterone Receptor Positive, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIC Breast Cancer, Tubular Breast Carcinoma

Intervention / Treatment
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* Procedure: Therapeutic Conventional Surgery
* Radiation: Radiation Therapy
* Other: Laboratory Biomarker Analysis
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and NOS (not otherwise specified); invasive lobular cancer is excluded Age >= 50 years and postmenopausal with no menses for at least one year prior to study enrollment Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility) Hormone receptor status Estrogen or progesterone receptor positive or Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cm Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysis Tumor >= 0.5 cm from skin as defined by breast ultrasound Unicentric tumor Axillary lymph nodes negative by pre-operative physical examination in all cases and pathologic examination from surgery for invasive disease Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation Exclusion Criteria: Initial core biopsy showing invasive lobular cancer Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization [FISH]) Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2 Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants Clinically or pathologically positive axillary lymph nodes Any prior breast cancer Prior breast radiation therapy

Ages Eligible for Study
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Minimum Age: 50 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: Treatment (radiation therapy)<br>Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. | Procedure: Therapeutic Conventional Surgery<br>* Undergo wide local excision breast surgery<br>Radiation: Radiation Therapy<br>* Undergo SFRT<br>* Other names: RT;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0. | Up to 2 years | 
| Quality-of-life Assessments | Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16. | Up to 2 years | 
| Cosmetic Differences in the Treated Breast | Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional Control Rate | Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates. | At 5 years | 
| Overall Survival | The overall survival will be analyzed using Kaplan-Meier method. | Up to 5 years | 
| Disease Specific Survival | The disease specific survival will be analyzed using Kaplan-Meier method. | Up to 5 years |