RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2020-06-30
Study Completion:2035-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04371913

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.

Ages Eligible for Study:19 Years to 90 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Isolated ipsilateral unifocal breast lesions
  2. * Limited size (\< 2-3 cm) without evidence of skin involvement
  3. * Histologically proven invasive breast carcinoma or carcinoma in situ
  4. * Negative histologic margins of resection
  5. * Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
  6. * No synchronous distant metastases
  7. * Age ≥ 18 years
  8. * ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
  9. * Previous WBI or IORT, brachytherapy or external beam partial breast treatment
  10. * Technical feasibility
  11. * Every kind of systemic therapy is allowed
  12. * Informed consent for clinical and research purposes signed
  1. * Regional recurrences (axillary, supraclavicular)
  2. * Positive histologic margins at resection
  3. * Metastatic disease
  4. * Poor cosmesis from previous surgery and RT
  5. * Extensive Intraductal Component

Contacts and Locations

Study Contact

Fabiana Gregucci
CONTACT
646-962-3110
fgr4002@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 10065
United States
New York Presbyterian Hospital - Queens
New York, New York, 10065
United States
Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-30
Study Completion Date2035-12-31

Study Record Updates

Study Start Date2020-06-30
Study Completion Date2035-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer