Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
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.
Arms & 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)
Outcome measures
Primary
Rate of treatment related adverse events as graded by CTCAE version 5.0
The primary endpoint of the study is to test the feasibility in terms of acute toxicity of a protocol of partial breast re-irradiation for breast cancer treatment in a previously irradiated whole breast, as defined by the rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain AEs, as graded by CTCAE version 5.0.
Time frame: up to 1 year from completion of radiation treatment
Secondary
Number of participants with late toxicity will be measured as graded by CTCAE version 5.0
Time frame: up to 60 months
Change in number of participants with skin changes
Time frame: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.
Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS)
Time frame: baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.
Number of participants who demonstrate local control
Time frame: 60 months
Disease free survival (DFS) will be measured
Time frame: 60 months
Overall Survival (OS) will be measured.
Time frame: 60 months
Number of participants who received subsequent mastectomy in the treated breast
Time frame: 6 months
Number of participants who received subsequent mastectomy in the treated breast
Time frame: 12 months
Number of participants who received subsequent mastectomy in the treated breast
Time frame: 24 months
Number of participants who received subsequent mastectomy in the treated breast
Time frame: 36 months
Number of participants who received subsequent mastectomy in the treated breast
Time frame: 48 months
Number of participants who received subsequent mastectomy in the treated breast
Time frame: 60 months
Eligibility criteria
Study locations (3)
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 10065
New York Presbyterian Hospital - Queens
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065