RecruitingNot ApplicableNCT04371913

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

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

Sponsor

Weill Medical College of Cornell University

Enrollment

120 participants

Start Date

Jun 30, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 19 YearsMax Age: 90 Years

Inclusion Criteria12

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 Criteria5

Regional recurrences (axillary, supraclavicular)
Positive histologic margins at resection
Metastatic disease
Poor cosmesis from previous surgery and RT
Extensive Intraductal Component

Interventions

RADIATION600cGY x 5 fractions APBI

Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using EBRT

RADIATION270cGy x 15 fractions 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)