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

Description

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.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study 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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Brooklyn

New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States, 10065

New York

New York Presbyterian Hospital - Queens, New York, New York, United States, 10065

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

19 Years to 90 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

John Ng, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2027-12-31