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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: 600cGY x 5 fractions


Participation Criteria
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Eligibility Criteria
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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 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 Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment Extensive Intraductal Component

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radiation Therapy<br>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 External Beam Radiation Therapy (EBRT). | Radiation: 600cGY x 5 fractions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 1 year from completion of radiation treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with late toxicity will be measured as graded by CTCAE version 5.0 | Late toxicity is defined as the adverse events experienced by patients after 90 days post radiation therapy. | up to 60 months | 
| Change in number of participants with skin changes | This count of participants will include patients who experience the following: skin hyperpigmentation, fibrosis, telangiectasia, skin induration and edema. | 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) | The Breast Cancer Treatment Outcomes Scale (BCTOS) will be used to evaluate patient-reported cosmetic outcome, functional status, and breast pain. Each BCTOS subscale (cosmetic, functional status, and breast pain) is calculated by computing the arithmetic mean of the answers to each item relevant to a given subscale. The score is a continuous variable ranging from 1 to 4, with 1 indicating no difference between the treated and untreated breast, 2 indicating a slight difference, 3 indicating a moderate difference, and 4 indicating a large difference. | 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 | Patients will be followed for recurrence of cancer in the treated breast. | 60 months | 
| Disease free survival (DFS) will be measured |  | 60 months | 
| Overall Survival (OS) will be measured. |  | 60 months | 
| Number of participants who received subsequent mastectomy in the treated breast | The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast | 6 months | 
| Number of participants who received subsequent mastectomy in the treated breast | The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast. | 12 months | 
| Number of participants who received subsequent mastectomy in the treated breast | The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast. | 24 months | 
| Number of participants who received subsequent mastectomy in the treated breast | The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast. | 36 months | 
| Number of participants who received subsequent mastectomy in the treated breast | The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast. | 48 months | 
| Number of participants who received subsequent mastectomy in the treated breast | The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast. | 60 months |