Using a Blood Test to Monitor Metastatic Breast Cancer Treatment (BEACON)

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer

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 newly diagnosed with metastatic breast cancer or women beginning a new line of 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: Observational
• Enrollment (Estimated): 150

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

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5P9
      • Recruiting
      • Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario
      • Contact: Josee-Lyne Ethier, MD, M.Sc.; Phone Number: 4505 613-544-2631; Email: josee-lyne.ethier@kingstonhsc.ca
    • Ottawa, Ontario, Canada, K1H 8L6
      • Not yet recruiting
      • The Ottawa Hospital Cancer Centre
      • Contact: Arif Awan, MD; Phone Number: 70179 613-737-7700; Email: aawan@ohri.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted on both women with newly diagnosed metastatic breast cancer and women previously treated with metastatic breast cancer who are starting a new line of therapy, regardless of treatment or breast cancer subtype.

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']
• De novo metastatic disease or radiographic disease progression on last treatment regimen. Patients already enrolled can be included in a new round if they progress on previous treatment.
• Planning to start new systemic therapy regimen at discretion of treating physician, per standard of care.
• Measurable disease as defined by RECIST v.1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
• A baseline CT scan must have been done within 6 weeks of entry into the trial

Exclusion Criteria

• Patients with exclusive bone metastases (which make up 20-30% of patients), which cannot be evaluated by RECIST, will be excluded except if they have measurable lytic lesions.

Study Plan

How is the study designed?

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline - 6 months

Collaborators and Investigators

• Sponsor: Dr. Christopher Mueller
• Collaborators: Canadian Institutes of Health Research (CIHR); Queen's University
• Investigators: Principal Investigator: Christopher R Mueller, Ph.D., Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Metastatic Breast Cancer; Liquid Biopsy; DNA Methylation; Circulating Tumour DNA; Treatment Response
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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: No
• Studies a U.S. FDA-regulated device product: No