Personalized approach for breast conservation in patients with recurrence
Official title: Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
Run by Weill Medical College of Cornell University · NCT04371913 · Data updated 2026-11-12
This study is testing a new way to safely treat breast cancer again with targeted radiation for patients who have had a recurrence after a previous lumpectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 90 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 3 sites (Brooklyn, New York and 2 other locations) |
| Status | Recruiting |
| Started | June 30, 2020 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2035 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT04371913 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with isolated unifocal breast lesions that are limited in size and have negative histologic margins after previous breast-conserving therapy.
✕Probably not a fit
Patients with regional recurrences, positive margins, or extensive intraductal components are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the feasibility of providing a second chance for breast conservation in patients who have experienced in-breast recurrences after a previous lumpectomy and radiation therapy. Participants will receive partial breast irradiation targeting the surgical bed with specific margins, using an accelerated fractionation scheme of 30 Gy over 5 fractions within 1-2 weeks. The primary aim is to evaluate the rate of early grade 3 toxicities associated with this treatment approach.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with breast cancer recurrence, potentially preserving breast tissue while minimizing toxicity.
How similar studies have gone: Other studies have explored similar approaches in breast cancer treatment, but this specific method of partial breast irradiation for recurrent cases is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Isolated ipsilateral unifocal breast lesions * Limited size (\< 2-3 cm) without evidence of skin involvement * Histologically proven invasive breast carcinoma or carcinoma in situ * Negative histologic margins of resection * Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension * No synchronous distant metastases * Age ≥ 18 years * ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence * Previous WBI or IORT, brachytherapy or external beam partial breast treatment * Technical feasibility * Every kind of systemic therapy is allowed * Informed consent for clinical and research purposes signed Exclusion Criteria: * Regional recurrences (axillary, supraclavicular) * Positive histologic margins at resection * Metastatic disease * Poor cosmesis from previous surgery and RT * Extensive Intraductal Component
Where it's running
-
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States Recruiting -
New York Presbyterian Hospital - Queens
New York, New York, United States Recruiting -
Weill Cornell Medicine
New York, New York, United States Recruiting
Study contacts
- Principal investigator: John Ng, M.D. — Weill Medical College of Cornell University
- Study coordinator: Fabiana Gregucci
- Email: fgr4002@med.cornell.edu
- Phone: 646-962-3110
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.