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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age50 Years to no maximum
• SexFemale
• Healthy volunteersNo

You may be able to join if

• 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.

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Breast Radiotherapy (Radiation): The tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• questionnaires: Part of the study plan
• radiation: Part of the study plan

Main goals

• Rate of any moderate-marked adverse effects (1 year)

Other goals

• In-breast tumor recurrence
• Quality of life at measured by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30)

Planned enrollment: 90 (estimated).

• University of North Carolina, Chapel Hill, North Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06902311

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 2, 2026. Public record; not medical advice.