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Protocol No. UW17125

Principal Investigator Neuman, Heather

Phase III (Cancer Control)

Age Group Adult

Scope National

Sponsor Type Industry

Title Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low-Risk DCIS: A Phase III Prospective Randomized Trial (AFT-25)

Objective The purpose of this study is to compare the risks and benefits of the usual treatment approach for DCIS compare to the close monitoring approach

Treatment Randomized to two groups:
  • Group 1: Usual treatment, this will include surgery, radiation or both. You will also have the choice of receiving endocrine(hormone-blocking) therapy. Additionally you will have mammograms every 12 months for 5 years
  • Group 2: Close monitoring. You will also have the choice of receiving endocrine(hormone-blocking) therapy. Additionally you will have mammograms(or possibly MRI's and/or ultrasounds) every 6 months for 5 years

  • Description A phase III prospective randomized trial for low risk DCIS

    Key Eligibility
  • New diagnosis of DCIS without invasive cancer (date of diagnosis is defined as the date of the pathology report that diagnosed the patient with DCIS). The following diagnoses are eligible, provided that the absence of invasive cancer can be confirmed and all other eligibility criteria are met: Unilateral, bilateral, unifocal, or multifocal DCIS Papillary in situ carcinoma
  • A patient who has had a lumpectomy with positive margins is eligible (subject to post-excision mammogram at enrollment)
  • No history of breast cancer (DCIS or invasive cancer) in either breast prior to current DCIS diagnosis
  • 40 years of age or older at time of DCIS diagnosis
  • ECOG performance status 0 or 1
  • Bilateral mammogram within 6 months of registration; ipsilateral breast imaging within 90 days of registration (can include mammogram, ultrasound, or breast MRI)
  • Pathologic diagnosis of DCIS
  • Histology slides reviewed and diagnosis confirmed by concordance among two clinical pathologists, not required to be at same institution. In cases of discordance between the two pathology reviews, a third pathology review is required
  • Grade I/II DCIS without invasion or microinvasion
  • Diagnosis confirmed on core needle, vacuum-assisted or surgical biopsy within 90 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
    EXCLUSION:
  • Male DCIS
  • DCIS with necrosis of any type or amount (except for ┬ôsingle-cell┬ö necrosis)
  • Concurrent diagnosis of invasive breast cancer in either breast, including microinvasion
  • Mass on examination or imaging at site of DCIS prior to biopsy yielding diagnosis of DCIS, with exception of fibroadenoma at a distinct/separate site from site of DCIS
  • patient who has had a mastectomy of the affected breast
  • Bloody nipple discharge
  • Mammographic finding of BIRADS 4 or greater at site other than that of known DCIS within 6 months of registration
  • 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

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park