Partial Breast Proton Therapy for Early Stage Breast Cancer

Study Overview
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Brief Summary
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The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.

Detailed Description
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Radiation therapy delivered to the whole breast is standard treatment following tumor removal for patients with early stage breast cancer. In selected patients, delivering the radiation treatment to only the part of the breast involved by the tumor may be a viable alternative. This can decrease the amount of normal tissues exposed to irradiation, potentially decrease side-effects and shorten the treatment time. Proton beam can decrease the volume of normal tissues treated compared to standard forms of radiotherapy. This study will recruit patients with early stage breast cancer following surgical removal to undergo partial breast radiotherapy with proton beam and determine the recurrence rates and side-effects of treatment.

Official Title
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Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Proton Beam Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast carcinoma DCIS Age 40 years or higher Primary tumor 3 cm or less Lumpectomy with clip placement Axillary node sampling Negative margins Exclusion Criteria: Distant metastasis Multicentric disease Prior radiation or chemotherapy Active collagen vascular disease Pregnant or lactating BRCA mutation Lymph nodes with more than microscopic tumor involvement

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Partial Breast Proton Therapy<br>Two weeks of daily proton therapy delivered to the lumpectomy site. | Radiation: Proton Beam Radiotherapy<br>* Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence in the breast |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of breast recurrence of low versus intermediate risk patients |  | 5 years | 
| Side-effects related to treatment |  | 5 years | 
| Disease Free Survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Partial Breast, Proton Beam