Comparing two radiation therapy schedules for breast cancer using proton therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates the effects of hypofractionated proton radiation therapy, which involves a shorter treatment duration of three weeks, compared to the conventional five-week regimen for women with breast cancer. The study aims to determine if the shorter treatment schedule results in similar rates of skin and soft tissue side effects as the longer standard treatment. Patients with Stage I-III breast cancer who have undergone surgery and require postoperative radiation therapy are eligible for participation. The study utilizes advanced proton therapy techniques to target the breast and regional lymph nodes effectively.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN)
* Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, metaplastic, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended
* No clinical evidence or suspicion of distant metastatic disease
* History and physical exam within 90 days prior to study registration
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Negative pregnancy test for women of child-bearing potential
* Able to begin radiation treatment within 12 weeks of last surgery or last day of chemotherapy
* Presence of breast implants, breast expanders, tissue flap, or other breast reconstruction are allowed
* Bilateral breast cancer is allowed if at least one side will be treated with comprehensive nodal irradiation per protocol treatment and will be recorded as the laterality receiving comprehensive nodal irradiation. If both sides will be treated comprehensively, it will be documented as such

Exclusion Criteria:

* Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of inflammatory breast cancer (T4d disease)
* Residual gross disease detected by imaging or clinical exam with the exception of \<2cm internal mammary lymph node or supraclavicular lymph node amenable to sequential boost
* Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy)
* Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction
* Presence of double/dual port tissue expander
* Clinical or radiographic evidence of distant metastatic disease
* Pregnant or breast-feeding females
* Non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
* History of connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
* Known BRCA 1 or BRCA 2 mutation
* Presence of an active skin rash
* Prior history of breast cancer
* Prior invasive non-study malignancy unless disease free for ≥ 3 years. Non-melanoma skin cancer, well-differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.

Where it's running

• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• California Protons Cancer Therapy Center
  San Diego, California, United States Recruiting
• University of Florida Proton Therapy Institute
  Jacksonville, Florida, United States Recruiting
• Dwoskin Proton Therapy Center
  Miami, Florida, United States Recruiting
• Miami Cancer Institute
  Miami, Florida, United States Recruiting
• Emory Proton Therapy Center
  Atlanta, Georgia, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.