Proton versus Photon Radiation Therapy and its Impact on Normal Tissue in Patients with Non-Metastatic Breast Cancer

Status: closed to accrual

This clinical trial compares the effect of proton radiation therapy versus photon radiation therapy and its impact on normal tissues in patients with breast cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Proton radiation therapy delivers the radiation directly to the target of the cancer instead of throughout the body. Photon radiation therapy delivers radiation to the area with cancer but can also deliver low doses of radiation, unintentionally, to nearby normal tissue. This trial may help researchers determine whether proton radiation therapy results in less myocardial fibrosis (scarring of the heart muscle) compared to photon radiation therapy in patients with non-metastatic breast cancer.

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 left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study principal investigator (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 other 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)

PRIMARY OBJECTIVE:

I. To determine if accelerated proton beam radiation (PBT) is associated with less myocardial fibrosis than accelerated conventional radiation therapy (XRT).

SECONDARY OBJECTIVES:

I. To measure cardiac function and cardiac injury after accelerated PBT compared to accelerated XRT.

II. To compare the potential differences between accelerated PBT and XRT patients in:

IIa. The change in global longitudinal strain (GLS) on cardiovascular magnetic resonance (CMR);

IIb. Diastolic strain rate through exploratory diastolic strain measurements;

IIc. Stability in cardiac biomarkers and pro-fibrotic cytokines;

IId. Cosmesis/reconstruction evaluation;

IIe. Shoulder function.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo accelerated XRT once daily (QD) 5 days a week for 1 week. Patients also undergo cardiac magnetic resonance imaging (MRI) at baseline, at 6 month follow up, and optionally at 18 month follow up, as well as collection of blood samples throughout the trial.

ARM II: Patients undergo accelerated PBT QD 5 days a week for 1 week. Patients also undergo cardiac MRI at baseline, at 6 month follow up, and optionally at 18 month follow up, as well as collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up for 18 months.

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Proton versus Photon Radiation Therapy and its Impact on Normal Tissue in Patients with Non-Metastatic Breast Cancer

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