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Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
Who can join
Ages 19 to 90 · Women
Full 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
About the study
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.
An additional goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with inbreast recurrences after a previous lumpectomy and PBI, the investigators propose to test whole breast RT (WBRT) with the target as the whole breast volume.
What is being tested
- 600cGY x 5 fractions APBI (radiation)
- 270cGy x 15 fractions WBRT (radiation)
Sponsor: Weill Medical College of Cornell University · Participants: 120 · Started: Jun 30, 2020
Contact the study team
- Fabiana Gregucci · Phone: 646-962-3110
Official record on ClinicalTrials.gov — NCT04371913
Locations in the U.S.
| New York | New York Presbyterian Brooklyn Methodist Hospital, Brooklyn New York Presbyterian Hospital - Queens, New York Weill Cornell Medicine, New York |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.