Status:
RECRUITING
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Breast Cancer
Early-stage Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
Brief Summary
This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast i...
Detailed Description
Multiple recent studies demonstrate the noninferiority of a simultaneous integrated boost (SIB) approach. This study will include women aged 50 years and older who are recommended to receive whole bre...
Eligibility Criteria
Inclusion
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- 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
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06902311
Start Date
March 12 2025
End Date
February 1 2028
Last Update
March 30 2025
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599