Protocol Summary

Protocol No.

100288 (AFT-25)

Principal Investigator

Matsen, Cindy

Phase

III

Age Group

Adult

ClinicalTrials.Gov

NCT02926911 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Contact

Title

Alliance Foundation Trials, LLC / Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial

Objective

<span style="line-height: 107%; font-family: "Calibri",sans-serif; font-size: 11pt; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"><font color="#000000">To study 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 DCIS using an AS approach does not yield inferior cancer or quality of life outcomes compared to surgery.</font></span>



<u><strong>Primary Objective:</strong></u>



<span style="font-size: 11pt;"><font color="#000000" face="Calibri">To assess whether 2-year ipsilateral invasive breast cancer rate for AM is non-inferior to that for surgery. </font></span>



 



<u><strong><span style="font-size: 11pt;"><font color="#000000" face="Calibri">Secondary Objectives:</font></span></strong></u>



To determine whether AM is non-inferior to surgery for the following outcomes: 2, 5, 7 and 10 year mastectomy rate, breast conservation rate, contralateral invasive breast cancer rate, overall survival and invasive breast cancer specific survival;<u> </u>5, 7 and 10 year ipsilateral invasive breast cancer rate; health-related QOL, anxiety and depression at baseline, 6 months, 1 year and annually year 2-5; coping at baseline; intolerance of uncertainty at baseline and 2 years.<span style="font-size: 11pt;"><font color="#000000" face="Calibri"> </font></span>

Applicable Disease Sites

Breast

Participating Institutions

HCI Farmington : Celine Saenz; HCI South Jordan : Celine Saenz; HCI Sugar House : Celine Saenz; Huntsman Cancer Institute : Celine Saenz

Status

Open


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