Radiation therapy for early-stage breast cancer using a shorter treatment schedule

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Ethan Steele, MD, MS — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Chasity McCue
• Email: chasity_mccue@med.unc.edu
• Phone: 919-966-4432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.