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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    30
  • sponsor
    Weill Medical College of Cornell University
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Updated on 19 February 2024
See if I qualify
metastasis
breast carcinoma
lumpectomy
invasive breast cancer
carcinoma
systemic therapy
breast irradiation
partial breast irradiation
radiotherapy to breast

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.

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) nave 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.

Details
Condition Breast Cancer, Breast Cancer
Age 19years - 90years
Treatment 600cGY x 5 fractions
Clinical Study IdentifierNCT04371913
SponsorWeill Medical College of Cornell University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Isolated ipsilateral unifocal breast lesions
Limited size (< 2-3 cm) without evidence of skin involvement
Histologically proven invasive breast carcinoma
Negative histologic margins of resection
Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
No synchronous distant metastases
Age 50 years
months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
Patient preference
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
Clear my responses
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