Clinical trial NCT05804578: Using a Blood Test to Monitor Metastatic Breast Cancer Treatment
Official title: Using a Liquid Biopsy to Monitor Metastatic Breast Cancer Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Breast Cancer
Keywords: Liquid Biopsy
Treatment Response
Circulating Tumour DNA
DNA Methylation
Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Queen's University
First posted: 2023-04-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in ctDNA level from baseline to 6 months of treatment
timeFrame: Baseline - 6 months
measure: Changes in radiographic tumour assessments for monitoring response to treatment
timeFrame: 3 months and 6 months
measure: Change in measurable lytic lesions in participants with bone only metastasis assessed by CT scans as measured per RECIST v.1.1
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Progression-free survival in patients with increasing, stable, and decreasing ctDNA levels during treatment
timeFrame: Baseline - 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Christopher R Mueller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: