Metastatic Breast CancerBEACONNCT05804578
Using a Blood Test to Monitor Metastatic Breast Cancer Treatment
An observational study of Metastatic Breast Cancer, run by Dr. Christopher Mueller at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Oct 2023to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- -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']
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario
Kingston, Ontario, K7L 5P9
Brooke Wilson, MBBS, MSc, FRACP, (613) 548-3232, brooke.wilson@kingstonhsc.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Katarzyna Jerzak, MD, MSc, FRCPC, 416-480-5248, katarzyna.jerzak@sunnybrook.ca
About this study
Official title: Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment
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.
Read the detailed description
Breast cancer is the most common cancer in Canadian women. While survival rates for women with metastatic breast cancer have almost doubled in the last 20 years, the 5-year survival rate is about 25%. Currently, determining whether a breast cancer therapy is working is very difficult. Women undergo CT-scans every three months to assess the effectiveness of their therapy. If the chosen treatment is not effective, a patient would have been delayed in receiving a more effective treatment and will be exposed to the serious side effects of their ineffective treatment during this time.
The investigators have developed a blood test, called mDETECT, which is a DNA methylation-based liquid biopsy that targets multiple tumour specific hypermethylated regions on DNA. DNA shed from tumours travels through the blood stream and which can be collected through a blood draw and analyzed for breast cancer specific methylation patterns. The mDETECT breast cancer assay is sensitive and specific and has been proven to work well in detecting breast cancer in women with metastatic disease. This assay has been designed to work with all subtypes of breast cancer. Moreover, this blood test measures changes in the size of the tumour; therefore, it will work with any treatment.
The goal of this observational study is to assess the effectiveness of the mDETECT breast cancer blood test in women undergoing treatment for metastatic breast cancer to determine if a response to therapy can be seen earlier than the current 3 month time point for CT-scans. In this study, women undergoing treatment for metastatic breast cancer will be recruited. Participants will have blood drawn at baseline and multiple timepoints throughout treatment. The participants will also be monitored using the current standard of care, imaging every 3 months with CT-scans. The aim of this study will be to determine if the mDETECT blood test can predict within the first few weeks of treatment the results of the 3 month CT-scan.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Liquid Biopsy, Treatment Response, Circulating Tumour DNA, DNA Methylation, Breast Cancer, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 3 months and 6 months
Secondary outcomes (1)
Progression-free survival in patients with increasing, stable, and decreasing ctDNA levels during treatment
Progression-free survival is the time from enrolment in the study to disease progression
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start19 Oct 2023
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Christopher Mueller
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Queen's University
- Responsible party
- Sponsor-investigator, Dr. Christopher Mueller, Queen's University
- Investigators
- Christopher R Mueller, Ph.D., Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804578
- Sponsor's protocol ID
- 6037248
- Other IDs
- 486377
- Acronym
- BEACON
- Status last verified
- May 2025
- First submitted
- 27 Mar 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT05804578
- Acronym / sponsor ID
- BEACON / 6037248
- Conditions
- Metastatic Breast Cancer
- Keywords
- Liquid Biopsy, Treatment Response, Circulating Tumour DNA, DNA Methylation, Breast Cancer, Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dr. Christopher MuellerUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Queen's University
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the most common cancer in Canadian women. While survival rates for women with metastatic breast cancer have almost doubled in the last 20 years, the 5-year survival rate is about 25%. Currently, determining whether a breast cancer therapy is working is very difficult. Women undergo CT-scans every three months to assess the effectiveness of their therapy. If the chosen treatment is not effective, a patient would have been delayed in receiving a more effective treatment and will be exposed to the serious side effects of their ineffective treatment during this time.
The investigators have developed a blood test, called mDETECT, which is a DNA methylation-based liquid biopsy that targets multiple tumour specific hypermethylated regions on DNA. DNA shed from tumours travels through the blood stream and which can be collected through a blood draw and analyzed for breast cancer specific methylation patterns. The mDETECT breast cancer assay is sensitive and specific and has been proven to work well in detecting breast cancer in women with metastatic disease. This assay has been designed to work with all subtypes of breast cancer. Moreover, this blood test measures changes in the size of the tumour; therefore, it will work with any treatment.
The goal of this observational study is to assess the effectiveness of the mDETECT breast cancer blood test in women undergoing treatment for metastatic breast cancer to determine if a response to therapy can be seen earlier than the current 3 month time point for CT-scans. In this study, women undergoing treatment for metastatic breast cancer will be recruited. Participants will have blood drawn at baseline and multiple timepoints throughout treatment. The participants will also be monitored using the current standard of care, imaging every 3 months with CT-scans. The aim of this study will be to determine if the mDETECT blood test can predict within the first few weeks of treatment the results of the 3 month CT-scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- -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']
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in ctDNA level from baseline to 6 months of treatment
Time frame: Baseline - 6 months
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).
Changes in radiographic tumour assessments for monitoring response to treatment
Time frame: 3 months and 6 months
Radiographic tumor assessments will be performed as per RECIST v.1.1
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
1 secondary outcome
Progression-free survival in patients with increasing, stable, and decreasing ctDNA levels during treatment
Time frame: Baseline - 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher R Mueller, Ph.D. principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Dr. Christopher Mueller at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher R Mueller, Ph.D. (613-533-6751, muellerc@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ctDNA level from baseline to 6 months of treatment (time frame: Baseline - 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.