Ultrahypofractionation and Normal Tissue Toxicity

Mass General Brigham

Status

Active, not recruiting

Conditions

Breast Cancer Stage II

Breast Cancer

Breast Cancer Female

Breast Cancer Stage III

Myocardial Fibrosis

Treatments

Radiation: Accelerated Photon Radiation Therapy (XRT)

Radiation: Accelerated Proton Beam Radiation Therapy (PBT)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05912231

23-182

P01CA261669 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)

Full description

This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.

Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.

Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.

The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥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.

Exclusion criteria

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Accelerated Proton Beam Radiation Therapy (PBT) Group

Experimental group

Description:

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.

Treatment:

Radiation: Accelerated Proton Beam Radiation Therapy (PBT)

Accelerated Photon Radiation Therapy (XRT) Group

Experimental group

Description:

Treatment:

Radiation: Accelerated Photon Radiation Therapy (XRT)