Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

Not Applicable

Conditions: Invasive Breast Cancer

Interventions: Radiation: Proton Radiation

Registration Number: NCT01340495

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: UNKNOWN

Sex: All

Target Recruitment: 70

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton Radiation	Proton Radiation	Radiation therapy with proton beam

Primary Outcome Measures

Name	Time	Method
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event	From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome	From the start of treatment until 5 years post treatment
The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy	Baseline and then 4 and 8 weeks post treatment	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.
The Number of Participants With Acute Skin Toxicities	From the start of treatment until 3 months after the end of treatment	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).
Rate and Severity of Radiation Pneumonitis	From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.	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
Summary of Late Skin Toxicity	From 3 months after the end of treatment up to 5 years	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).
Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation	From the start of treatment until 5 years post treatment	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).
Progression Free Survival	from the start of treatment until the time of disease progression, up to 5 years	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.
The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction	From the start of treatment until 5 years post treatment