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Recruiting NCT05663294

PBI for Breast In Situ Carcinoma of Intermediate Low Risk as Local Adjuvant Treatment

Conditions: Breast Cancer

Sex: Female
Ages: 41 Years – N/A
Phase: NA
Enrollment: 150
Sponsor: Istituto Clinico Humanitas

Location: Italy

Summary

Screening and advances in breast imaging led to a continuous increase of Ductal Carcinoma in situ (DCIS) diagnosis. Whole breast radiotherapy was reported to be effective in reducing the risk of local recurrence in all analyzed patients and tumor characteristics. In order to de-escalate treatment in low and intermediate DCIS, it is possible to investigate the role of partial breast irradiation (PBI). To date, data from available literature supports the hypothesis that PBI is a safe well tolerated therapy that appears to be equivalent to WBI in terms of efficacy and ultimate breast cosmesis.

Eligibility Criteria

Inclusion Criteria:Age >40Pathologically confirmed DCIS:low risk (lesions of ≤3 cm diameter, resection margins of at least 2 mm, nuclei grade:intermediate risk (lesions of ≤1 cm diameter, resection margins of at least 2 mm, nuclei grade: 3)Written informed consentExclusion Criteria:Prior thoracic radiation therapyPreoperative systemic treatments (i. e., chemotherapy, endocrine therapy);Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelaeNo other cancers in the last 5 years

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05663294). StuddyBuddy aggregates publicly available trial information.