Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy (NCT05856773)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (13 items).
Location: Mayo Clinic — Scottsdale, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (9 Sites)
- Mayo Clinic — Scottsdale, Arizona
- California Protons Cancer Therapy Center — San Diego, California
- University of Florida Proton Therapy Institute — Jacksonville, Florida
- Dwoskin Proton Therapy Center — Miami, Florida
- Miami Cancer Institute — Miami, Florida
- Emory Proton Therapy Center — Atlanta, Georgia
- Maryland Proton Treatment Center — Baltimore, Maryland
- New York Proton Center — New York, New York
- Inova Schar Cancer Institute — Fairfax, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.