Radiation therapy for inoperable breast cancer
Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
This trial will try adding a short, high-dose whole-breast radiation course with a focused boost to usual breast cancer medicines for people with locally advanced breast cancer who cannot or do not want surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stony Brook University Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT07122713 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with biopsy-proven invasive breast cancer (T1–T4, N0–2, M0–1) judged unresectable or who decline surgery, with life expectancy greater than six months and a negative pregnancy test for women of reproductive age.
Not a fit: Patients who previously received radiation to the same breast or regional nodes, those unable to undergo treatment planning or delivery due to body habitus, or those requiring concurrent cytotoxic systemic therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide durable local tumor control and symptom relief for patients who cannot undergo surgery, potentially reducing local progression and the need for more aggressive systemic therapies.
How similar studies have performed: Radiation is well established as effective after surgery and there is growing but limited evidence that high-dose, ultra-hypofractionated radiation with a boost can provide durable control in unresectable breast tumors, so this approach is promising but not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stony Brook, New York
- 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
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.