Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Invasive Breast Cancer
• Intervention / Treatment: Radiation: Proton Radiation

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proton Radiation; Radiation therapy with proton beam	Radiation: Proton Radiation; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Shannon M MacDonald, M.D., Massachusetts General Hospital

Publications and helpful links

General Publications

• Jimenez RB, Hickey S, DePauw N, Yeap BY, Batin E, Gadd MA, Specht M, Isakoff SJ, Smith BL, Liao EC, Colwell AS, Ho A, Januzzi JL, Passeri J, Neilan TG, Taghian AG, Lu HM, MacDonald SM. Phase II Study of Proton Beam Radiation Therapy for Patients With Breast Cancer Requiring Regional Nodal Irradiation. J Clin Oncol. 2019 Oct 20;37(30):2778-2785. doi: 10.1200/JCO.18.02366. Epub 2019 Aug 26.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2017
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: April 20, 2011
• First Submitted That Met QC Criteria: April 20, 2011
• First Posted (Estimate): April 22, 2011

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Breast Cancer; Mastectomy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 10-205