Proton Therapy for Early Stage Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

Detailed Description
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Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.

Official Title
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Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer

Conditions
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Early-Stage Breast Cancer

Intervention / Treatment
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* Radiation: Proton radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive ductal, medullary, papillary, colloid or tubular histologies Stages T1 or T2 (tumors < or = 3 cm) from lumpectomy specimen. No more then 3 positive nodes on axillary dissection or negative sentinel node. Negative surgical margins (>2mm) Exclusion Criteria: Invasive lobular histology Previous chemotherapy for breast cancer Extensive intraductal component Collagen vascular disease Prior malignancy unless disease-free for 5 years Patients who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 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: Proton Radiotherapy<br>Two week course of proton radiotherapy to the breast. | Radiation: Proton radiation therapy<br>* Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ipsilateral Breast Tumor Recurrence-free Survival | Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam | Up to 5 years post-treatment completion, average of 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival rate at 5 years post-treatment completion. | Up to 5 years post- completion of treatment, average 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton, Radiation, Breast cancer