BEACON: Using a Blood Test to Monitor Metastatic Breast Cancer Treatment

Sponsor

Dr. Christopher Mueller (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05804578

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), Queen's University (Other)

150

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

We 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. They will have blood drawn at baseline and multiple timepoints throughout treatment. The patients 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

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Outcome Measures

Primary Outcome Measures

Change in ctDNA level from baseline to 6 months of treatment [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 [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 [3 months and 6 months]

Secondary Outcome Measures

Progression-free survival in patients with increasing, stable, and decreasing ctDNA levels during treatment [Baseline - 6 months]
Progression-free survival is the time from enrolment in the study to disease progression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario	Kingston	Ontario	Canada	K7L 5P9
2	The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6