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Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

Trial

Clinical Trial Title

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

Trial Status

Open to Enrollment

Start Date

June 15, 2020

Trial Type

Cancer - Adult Oncology

Specific Condition

Breast cancer

Description

This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AM approach does not yield inferior cancer or quality of life outcomes compared to surgery.

Eligibility Criteria

Inclusion Criteria

  • New diagnosis of DCIS without invasive cancer; date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS
  • Unilateral, bilateral, unifocal, or multifocal DCIS
  • 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 time of DCIS diagnosis
  • ECOG performance status 0 or 1

Exclusion Criteria

  • All grade III DCIS
  • Concurrent diagnosis of invasive or microinvasive breast cancer in either breast
  • Use of investigational cancer agents within 6 weeks prior to diagnosis
  • Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene in last 6 months

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Nathalie Johnson, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:57:03 PM