Comparing proton and photon radiation therapy for breast cancer
Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
This study is testing whether proton beam radiation therapy is safer for the heart than traditional photon radiation therapy in patients with non-metastatic left-sided breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05912231 on ClinicalTrials.gov |
What this trial studies
This research compares the effects of proton beam radiation therapy (PBT) and conventional photon radiation therapy (XRT) on heart health in patients with non-metastatic left-sided breast cancer. Participants will be randomly assigned to receive either PBT or XRT, and their heart changes will be monitored using MRI imaging. The study aims to determine if PBT results in less cardiac toxicity compared to XRT. It includes screening, treatment visits, blood tests, and questionnaires to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-metastatic left-sided breast cancer scheduled for radiation therapy.
Not a fit: Patients with right-sided breast cancer or those not requiring treatment to the internal mammary lymph nodes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer radiation therapy options for breast cancer patients, minimizing heart damage.
How similar studies have performed: Other studies have shown promising results with proton therapy in reducing toxicity, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Jimenez, MD — Massachusetts General Hospital
- Study coordinator: Rachel Jimenez, MD
- Email: RBJIMENEZ@PARTNERS.ORG
- Phone: 617-726-8651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.