Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS

Summary

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.

Conditions

• DCIS
• Ductal Carcinoma in Situ

Interventions

OTHER

Surgery

Surgery +/- radiation choice for endocrine therapy

OTHER

Active Monitoring

Choice for endocrine therapy

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• New York University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Rising Tide Foundation

  collaborator OTHER

• Breast Cancer Research Foundation

  collaborator OTHER

• Alliance Foundation Trials, LLC.

  lead OTHER

Principal Investigators

• Shelley Hwang, MD, MPH · Duke University

• Ann Partridge, MD, MPH · Dana-Farber Cancer Institute

• Alastair Thompson, MD · Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-22

Primary Completion

2024-06-27

Completion

2030-07-31

Countries

• United States

Study Locations