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

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04371913

Patient View

This Phase II study evaluates partial breast irradiation for patients with in-breast recurrences post-lumpectomy and RT. It uses 30 Gy in 5 fractions over 1-2 weeks. Eligibility includes isolated unifocal lesions (<3 cm), histologically proven carcinoma, and no distant metastases. The primary aim is to assess early grade 3 toxicities.

Patient Parameters

Program 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 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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.