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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
New York Presbyterian Brooklyn Methodist Hospital
RECRUITING
Brooklyn
New York Presbyterian Hospital - Queens
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Fabiana Gregucci
fgr4002@med.cornell.edu
646-962-3110
Time Frame
Start Date: 2020-06-30
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 120
Treatments
Other: Radiation Therapy - PBI
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated partial breast irradiation (PBI) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
Other: Radiation Therapy - WBRT
Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov