Using a Blood Test to Monitor Metastatic Breast Cancer Treatment
BEACON
Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment
2 other identifiers
observational
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJuly 25, 2025
May 1, 2025
2.2 years
March 27, 2023
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in ctDNA level from baseline to 6 months of treatment
The change in circulating tumour DNA methylation level over the course of treatment (Baseline blood draw, with timing of every standard of care blood draw for 8 weeks after treatment initiation, then monthly with standard of care blood draw for up to six after treatment initiation).
Baseline - 6 months
Changes in radiographic tumour assessments for monitoring response to treatment
Radiographic tumor assessments will be performed as per RECIST v.1.1
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
3 months and 6 months
Secondary Outcomes (1)
Progression-free survival in patients with increasing, stable, and decreasing ctDNA levels during treatment
Baseline - 6 months
Eligibility Criteria
This study will be conducted on both women with newly diagnosed metastatic breast cancer and women previously treated with metastatic breast cancer, regardless of treatment or breast cancer subtype.
You may qualify if:
- 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 \[to be herein described as 'metastatic'\]
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Christopher Muellerlead
- Canadian Institutes of Health Research (CIHR)collaborator
- Queen's Universitycollaborator
Study Sites (2)
Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario
Kingston, Ontario, K7L 5P9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Biospecimen
Blood samples will be collected from participants
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher R Mueller, Ph.D.
Queen's University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 7, 2023
Study Start
October 19, 2023
Primary Completion
January 1, 2026
Study Completion
April 1, 2026
Last Updated
July 25, 2025
Record last verified: 2025-05