Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

Study Overview
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Brief Summary
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In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.

Detailed Description
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Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing. Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.

Official Title
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Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy

Conditions
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Invasive Breast Cancer

Intervention / Treatment
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* Radiation: Proton Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery Life expectancy > 12 months Exclusion Criteria: Pregnant or breast-feeding Prior therapeutic radiation > 200 cGy History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin Prior investigation chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 Radiation<br>Radiation therapy with proton beam | Radiation: Proton Radiation<br>* 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event | To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment. | From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Acute Skin Toxicities | Summary of the number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). | From the start of treatment until 3 months after the end of treatment | 
| Rate and Severity of Radiation Pneumonitis | The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-Threatening Grade 5: Fatal | From the start of treatment until 3 months after the end of treatment and was not included in the analysis population. | 
| Summary of Late Skin Toxicity | A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). | From 3 months after the end of treatment up to 5 years | 
| To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome |  | From the start of treatment until 5 years post treatment | 
| Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation | Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). | From the start of treatment until 5 years post treatment | 
| The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction |  | From the start of treatment until 5 years post treatment | 
| The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy | The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects. | Baseline and then 4 and 8 weeks post treatment | 
| Progression Free Survival | Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions. | from the start of treatment until the time of disease progression, up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Mastectomy