Using a Blood Test to Monitor Metastatic Breast Cancer Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment

Conditions
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Metastatic Breast Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liquid Biopsy, Treatment Response, Circulating Tumour DNA, DNA Methylation, Breast Cancer, Metastatic Breast Cancer