Breast Cancer Clinical Trial
Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
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 propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins.
Full 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 Presbyterian using EBRT.
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
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
Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment
Extensive Intraductal Component
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There is 1 Location for this study
Brooklyn New York, 10065, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
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