Actively Recruiting

Phase Not Applicable
Age: 19Years - 90Years
FEMALE
NCT04371913

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

Led by Weill Medical College of Cornell University · Updated on 2026-01-27

120

Participants Needed

3

Research Sites

808 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 90Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Isolated ipsilateral unifocal breast lesions
  • Tumor size less than 2-3 cm with no skin involvement
  • Histologically confirmed invasive breast carcinoma or carcinoma in situ
  • Negative surgical margins after resection
  • 0 to 3 positive axillary lymph nodes without extracapsular extension
  • No synchronous distant metastases
  • Age 18 years or older
  • At least 12 months between initial breast conserving therapy and recurrence
  • Previous whole breast irradiation or partial breast radiotherapy
  • Technical feasibility for study treatments
  • Any systemic therapy allowed
  • Signed informed consent for clinical and research purposes
Not Eligible

You will not qualify if you...

  • Regional recurrences in axillary or supraclavicular areas
  • Positive surgical margins after resection
  • Presence of metastatic disease
  • Poor cosmetic outcome from previous surgery and radiation
  • Extensive intraductal component

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States, 10065

Actively Recruiting

2

New York Presbyterian Hospital - Queens

New York, New York, United States, 10065

Actively Recruiting

3

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

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Research Team

F

Fabiana Gregucci

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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