Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Mar 24, 2025

Keywords

ClinConnect Summary

The H-ASSIST clinical trial is studying a new approach to radiation therapy for women with early-stage breast cancer, including a condition called ductal carcinoma in situ (DCIS). This trial is looking at a shorter radiation treatment plan that consists of just five sessions, which is designed to be as effective as the traditional longer treatment while reducing the number of visits needed. The study also aims to understand how this new method affects patients' quality of life and any side effects they might experience.

To participate in this trial, women must be 50 years or older and have had surgery for their breast cancer. They should have either invasive breast cancer or DCIS and must be willing to sign consent forms to join the study. Participants are required to have had successful breast-conserving surgery and plan to receive specific types of radiation therapy afterward. It's important to note that women with certain health conditions or previous treatments may not be eligible. If you join the trial, you can expect to receive radiation therapy that targets both the whole breast and the area around the tumor at the same time, which could help lower the chance of cancer returning.

Gender

FEMALE

Eligibility criteria

• • In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
• Inclusion Criteria:
• • Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• • Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.
• • Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
• • Subjects planned to receive either SOC whole breast 3D conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.
• • Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, per the discretion of the treating radiation oncologist.
• • Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator.
• Exclusion Criteria:
• • Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).
• • Synchronous bilateral breast cancer requiring bilateral radiation therapy.
• • Clinical or imaging evidence of distant metastases.
• • Prior ipsilateral breast or thoracic radiation.
• • Autoimmune conditions
• • Collagen Vascular Disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others)
• • Patients with pT4 tumors.
• • Patients recommended to receive regional nodal irradiation with associated radiation risks