Radiation therapy for inoperable breast cancer

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 open-label interventional protocol delivers ultra-hypofractionated whole-breast radiation with a simultaneous integrated boost (SIB) to the gross tumor, with some patients also receiving SIB to the ipsilateral axillary nodes. Eligible participants are those with biopsy-proven invasive breast carcinoma deemed unresectable or who decline surgery, and standard systemic therapy is permitted except for concurrent cytotoxic regimens (endocrine, HER2-targeted therapy, and immunotherapy are allowed). The goal is to deliver ablative radiation doses in fewer fractions to improve durable local control when surgery is not performed, while using modern planning to limit dose to normal tissues. Participation does not preclude future surgery and requires treatment planning visits and daily radiation sessions at the study center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
* T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
* Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
* Life expectancy \> 6 months
* Negative pregnancy test at the time of start of treatment in any female of reproductive age

Exclusion Criteria:

* Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
* Prior radiation to ipsilateral breast or regional nodes
* Inability to receive study treatment planning and treatment secondary to body habitus

Where it's running

• Stony Brook University Cancer Center
  Stony Brook, New York, United States Recruiting

Study contacts

• Principal investigator: Alexander Stessin, MD PhD — Stony Brook University Hospital
• Study coordinator: Caterina Stony Brook Cancer Center Clinical Trials
• Email: cancerclinicaltrials@sronybrookmedicine.edu
• Phone: 631-728-7425

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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.