Personalized Second Chance Breast Conservation (PSCBC): A 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.

Eligibility

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

Conditions2

Locations3 sites

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