Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
Recruiting · NCT04371913 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
270cGy x 15 fractions WBRT600cGY x 5 fractions APBI
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.
Who can take part
Age range
19 Years to 90 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- Previous WBI or IORT, brachytherapy or external beam partial breast treatment
- 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
- Extensive Intraductal Component
Where it is running
3 locations listed across 1 US state.
- New York Presbyterian Brooklyn Methodist Hospital - Brooklyn, New York, United States
- New York Presbyterian Hospital - Queens - New York, New York, United States
- Weill Cornell Medicine - New York, New York, United States