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

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.

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.

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
• 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 Criteria:

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