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H-ASSIST Study: Ultra Hypo-fractionated Radiation for Early-Stage Breast Cancer

This study, called H-ASSIST, is looking at a new way to give radiation therapy for early-stage breast cancer or ductal carcinoma in situ (DCIS). It tests a shorter radiation schedule of 5 treatments given every other day, called ultra hypo-fractionated whole breast radiation therapy (WBI). This treatment also includes a "simultaneous integrated boost" (SIB), which means a slightly higher dose of radiation is given to the area where the tumor was removed, at the same time as the whole breast radiation. The study wants to see how many patients experience moderate or marked side effects from this treatment after one year. It also looks at quality of life and how well the treatment controls the cancer. We are currently unclear on the study's recruitment status. Women aged 50 and older with confirmed invasive breast cancer or DCIS can join.

Study design
This is an interventional study planning to enroll 90 women. It is testing a specific radiation therapy approach.
What's involved
Participants will receive 5 radiation treatments delivered every other day (excluding weekends). They will have assessments by clinicians and patients at 12 months and 24 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for radiation-specific toxicity at 12 months, and for quality of life and oncologic control at 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06902311

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

Recruiting
PHASE2Ages 50+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~90 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Breast Radiotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of any moderate-marked adverse effects
Measured over 1 year

Conditions

Breast Cancer
Early-stage Breast Cancer
Ductal Carcinoma in Situ
DCIS

Explore related trials

Breast CarcinomaBreast Ductal Carcinoma In Situ

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Dana Casey, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Jessica Buddenbaum
[email protected]
919-966-4432
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of any moderate-marked adverse effects1 year

    The rate of moderate to marked adverse effects in the breast or chest wall at 1 year will be measured using a questionnaire called the Clinician Assessment of Radiation-Specific Toxicity by clinican. This will be compared against historical controls. The questionnaire includes 10 items: 4 Likert-type questions and 6 yes/no questions. Items are rated from 0 to 4, with higher scores indicating more adverse effects. A "yes" response indicates the occurrence of an adverse event.