Recruiting

mDETECT

Sponsor:

Dr. Christopher Mueller

Code:

NCT05804578

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to assess the effectiveness of the mDETECT breast cancer blood test at monitoring treatment response in women with metastatic breast cancer undergoing treatment.

Conditions

Metastatic Breast Cancer

Study ID

NCT05804578

Start date

Oct 19, 2023

Status verified date

May, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

-Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent \[to be herein described as 'metastatic'\]

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in ctDNA level from baseline to 6 months of treatment [ Time Frame: Baseline - 6 months ]
  • Changes in radiographic tumour assessments for monitoring response to treatment [ Time Frame: 3 months and 6 months ]
  • Change in measurable lytic lesions in participants with bone only metastasis assessed by CT scans as measured per RECIST v.1.1 [ Time Frame: 3 months and 6 months ]

Central Contacts and Locations

Central contacts

Christopher R Mueller, Ph.D.

613-533-6751muellerc@queensu.ca

Keira Frosst

613-533-677316kmf4@queensu.ca

Locations

Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario

Recruiting

Kingston, Ontario, Canada, K7L 5P9

Contacts

Brooke Wilson, MBBS, MSc, FRACP

(613) 548-3232brooke.wilson@kingstonhsc.ca

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Katarzyna Jerzak, MD, MSc, FRCPC

416-480-5248katarzyna.jerzak@sunnybrook.ca

More Information

Sponsor

Dr. Christopher Mueller

Last update posted

Jul 25, 2025

Last verified

May, 2025

Keywords

  • Liquid Biopsy
  • Treatment Response
  • Circulating Tumour DNA
  • DNA Methylation
  • Breast Cancer
  • Metastatic Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Christopher Mueller on 2025-07-25.