Radiation therapy for early-stage breast cancer using a shorter treatment schedule
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
This study is testing a shorter radiation treatment schedule for women 50 and older with early-stage breast cancer to see if it is safe and effective while reducing the number of visits needed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06902311 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a 5-fraction whole breast irradiation (WBI) regimen with a simultaneous integrated boost (SIB) for women aged 50 and older diagnosed with early-stage breast cancer or ductal carcinoma in situ. Participants will receive radiation therapy every other day, totaling 26 Gy to the whole breast and 30 Gy to the tumor bed. The primary focus is to assess radiation-specific toxicity, quality of life, and oncologic outcomes at 12 and 24 months post-treatment. This approach aims to minimize treatment visits while maintaining effective cancer control.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older who have undergone breast-conserving surgery for early-stage breast cancer or ductal carcinoma in situ.
Not a fit: Patients with advanced breast cancer or those who have not undergone breast-conserving surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more convenient and effective radiation therapy option for early-stage breast cancer patients, potentially improving their quality of life.
How similar studies have performed: Previous studies, such as the FAST-Forward trial, have shown success with shorter radiation schedules, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Dana Casey, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Jessica Buddenbaum
- Email: jessica_buddenbaum@med.unc.edu
- Phone: 919-966-4432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.