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Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study

Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study

Recruiting
19-90 years
Female
Phase 2

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Overview

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.

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

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

Study details
    Breast Cancer

NCT04371913

Weill Medical College of Cornell University

28 January 2024

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