New diagnosis of DCIS without invasive breast cancer Unilateral, bilateral, unifocal, or multifocal DCIS A patient who has had a lumpectomy with positive margins as part of their treatment for a current DCIS diagnosis is eligible No previous history of breast cancer (DCIS or invasive cancer) in either breast prior to current DCIS diagnosis 40 years of age or older at the time of DCIS diagnosis ECOG performance status 0 or 1 No contraindication for surgery Baseline imaging:
Pathological criteria: ADH suspicious for DCIS Any grade I or grade II DCIS Absence of invasive or microinvasive breast cancer Diagnosis confirmed on core needle, vacuum-assisted biopsy or surgery ≤120 days of registration ER(+) and/or PR(+) by IHC (≥10% staining or Allred score≥4) HER2 0, 1+ or 2+ by IHC if HER2 testing is performed
Histology slides reviewed and agreement between two clinical pathologists that pathology fulfils COMET eligibility criteria. At least two sites of biopsy for those cases where mammographic extent of calcifications exceeds 4 cm, with second biopsy benign or both sites fulfilling pathology eligibility criteria Amenable to follow-up examinations Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document in Spanish or English
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All grade III DCIS Male DCIS Concurrent diagnosis of invasive or microinvasive breast cancer in either breast prior to randomisation Documented mass on examination or imaging at the site of DCIS prior to biopsy yielding diagnosis of DCIS Bloody nipple discharge or skin changes associated with DCIS Mammographic finding of BI-RADS 4 or greater within 6 months of registration at site other than that of known DCIS, without pathological assessment Use of investigational cancer agents within 6 weeks prior to diagnosis Any serious and/or unstable pre-existing medical, psychiatric or other existing condition that would prevent compliance with the trial or consent process Pregnancy Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene in last 6 months
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