Using a Blood Test to Monitor Metastatic Breast Cancer Treatment (BEACON)
Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christopher R Mueller, Ph.D.
- Phone Number: 613-533-6751
- Email: muellerc@queensu.ca
Study Contact Backup
- Name: Keira Frosst
- Phone Number: 613-533-6773
- Email: 16kmf4@queensu.ca
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 5P9
- Recruiting
- Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario
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Contact:
- Brooke Wilson, MBBS, MSc, FRACP
- Phone Number: (613) 548-3232
- Email: brooke.wilson@kingstonhsc.ca
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Katarzyna Jerzak, MD, MSc, FRCPC
- Phone Number: 416-480-5248
- Email: katarzyna.jerzak@sunnybrook.ca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline - 6 months
|
|
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
|
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
|
3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival in patients with increasing, stable, and decreasing ctDNA levels during treatment
Time Frame: Baseline - 6 months
|
Progression-free survival is the time from enrolment in the study to disease progression
|
Baseline - 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher R Mueller, Ph.D., Queen's University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6037248
- 486377 (Other Grant/Funding Number: Canadian Institutes of Health Research)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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