NCT04371913

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 Radiation Therapy (RT) naïve patients at New York Presbyterian using EBRT or with the fractionation of 4050 cGy in 15 fractions over 3 weeks, based on the previous treatment that they received. The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	600cGY 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
RADIATION	270cGy 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)

Timeline

• Start date: 2020-06-30
• Primary completion: 2030-12-31
• Completion: 2035-12-31
• First posted: 2020-05-01
• Last updated: 2026-01-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study