General Information

Age Group

Status

Recruiting

Protocol Number

NCT05856773

Background Information

This study aims to assess whether a 3-week hypofractionated proton radiation therapy regimen for breast cancer, targeting the breast/chest wall and regional lymph nodes, is as effective as a traditional 5-week regimen in terms of skin and soft tissue side effects. Specifically, it seeks to determine if the shorter treatment duration results in comparable rates of both acute and late side effects when compared to the longer, conventionally fractionated proton therapy schedule.

For more information, visit: https://clinicaltrials.gov/study/NCT05856773

Offered At

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031
Principal Investigator

Ashish Chawla, MD

Eligibility Information

  • 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, 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
  • Documentation of negative metastatic workup by whole body Positron Emission Tomography - Computed Tomography (PET/CT) or by combined CT of the chest, abdomen, pelvis and Bone scan
  • History and physical exam within 90 days prior to study registration
  • Additional eligibility in protocol

Ineligibility Information

  • 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
  • Additional ineligibility in protocol