Ultrahypofractionation and Normal Tissue Toxicity

NCT05912231 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 23-182P01CA261669
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer. The names of the two study groups in this research study are:

• Proton Radiation Therapy (PBT)
• Conventional or "Photon" Radiation Therapy (XRT)

Conditions

Breast Cancer; Breast Cancer Female; Breast Cancer Stage II; Breast Cancer Stage III; Myocardial Fibrosis

Keywords

Radiation Therapy; Photon Radiation Therapy; XRT; Proton Beam Radiation Therapy; PBT; Breast Cancer; Breast Cancer Female; Breast Cancer Stage II; Breast Cancer Stage III; Myocardial Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)

  The primary outcome is to determine whether participants who receive accelerated PBT show no increase in myocardial fibrosis on Cardiac MRI (CMR) compared to an estimated 4% increase in extracellular matrix volume fraction (ECV) in participants who receive accelerated XRT. CMR will be performed using a 3T system (Skyra, Siemens). The T1 phase on MRI will be used to measure ECV.

  Up to 7 months (pre-treatment period to 6 month follow up)

Secondary Outcomes (4)

• Change in Global Longitudinal Strain (GLS) on CMR from Baseline

  Up to 7 months (pre-treatment period to 6 month follow up)

• Stability of Cardiac Biomarkers from Baseline

  Up to 7 months (pre-treatment period to 6 month follow up)

• Body Image Evaluation

  Up to 13 months (pre-treatment period to 12 month follow up)

• Change in Shoulder Function from Baseline

  Up to 13 months (pre-treatment period to 12 month follow up)

Study Arms (2)

Accelerated Proton Beam Radiation Therapy (PBT) Group

EXPERIMENTAL

Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete: * Cardiac MRI and blood tests within 1 month prior to start of radiation therapy. * Radiation therapy 1x daily for 5 days over 1 week. * End of radiation therapy visit with blood tests. * 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging. * 12 month follow up visit with questionnaires and photographic imaging.

Radiation: Accelerated Proton Beam Radiation Therapy (PBT)

Accelerated Photon Radiation Therapy (XRT) Group

EXPERIMENTAL

Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete: * Cardiac MRI and blood tests within 1 month prior to start of radiation therapy. * Radiation therapy 1x daily for 5 days over 1 week. * End of radiation therapy visit with blood tests. * 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging. * 12 month follow up visit with questionnaires and photographic imaging.

Radiation: Accelerated Photon Radiation Therapy (XRT)

Interventions

Accelerated Proton Beam Radiation Therapy (PBT) RADIATION

per protocol

Accelerated Proton Beam Radiation Therapy (PBT) Group

Accelerated Photon Radiation Therapy (XRT) RADIATION

per protocol

Accelerated Photon Radiation Therapy (XRT) Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All women of all races and ethnic groups are eligible for this trial.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
• Prior chemotherapy is permitted
• Ability to understand and the willingness to sign a written informed consent document
• No contraindication to MRI
• Patients with right-sided breast cancer or patients with left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study PI, will be considered eligible.

You may not qualify if:

• Person who is pregnant or breastfeeding.
• Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy.
• Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
• Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator
• American Society of Clinical Oncology: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel Jimenez, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)