Status:
RECRUITING
Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-90 years
Phase:
NA
Brief Summary
The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators pro...
Detailed Description
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for Radiation Therapy (RT) naïve patients at New York Pr...
Eligibility Criteria
Inclusion
- 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
- Technical feasibility
- Every kind of systemic therapy is allowed
- Informed consent for clinical and research purposes signed
Exclusion
- Regional recurrences (axillary, supraclavicular)
- Positive histologic margins at resection
- Metastatic disease
- Poor cosmesis from previous surgery and RT
- Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment
- Extensive Intraductal Component
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04371913
Start Date
June 30 2020
End Date
December 31 2027
Last Update
February 20 2025
Active Locations (3)
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1
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 10065
2
New York Presbyterian Hospital - Queens
New York, New York, United States, 10065
3
Weill Cornell Medicine
New York, New York, United States, 10065