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Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
NCT04371913 · Weill Medical College of Cornell University
In plain English
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Official title
Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
About this study
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 Presbyterian using EBRT or with the fractionation of 4050 cGy in 15 fractions over 3 weeks, based on the previous treatment that they received.
The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.
Eligibility 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
Study design
Enrollment target: 120 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-06-30
Estimated completion: 2035-12-31
Last updated: 2026-01-27
Interventions
Radiation: 600cGY x 5 fractions APBIRadiation: 270cGy x 15 fractions WBRT
Primary outcomes
- • Rate of treatment related adverse events as graded by CTCAE version 5.0 (up to 1 year from completion of radiation treatment)
Sponsor
Weill Medical College of Cornell University · other
Contacts & investigators
ContactFabiana Gregucci · contact · fgr4002@med.cornell.edu · 646-962-3110
InvestigatorJohn Ng, M.D. · principal_investigator, Weill Medical College of Cornell University
All locations (3)
New York Presbyterian Brooklyn Methodist HospitalRecruiting
Brooklyn, New York, United States
New York Presbyterian Hospital - QueensRecruiting
New York, New York, United States
Weill Cornell MedicineRecruiting
New York, New York, United States