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Trial Title:
Using a Blood Test to Monitor Metastatic Breast Cancer Treatment
NCT ID:
NCT05804578
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Liquid Biopsy
Treatment Response
Circulating Tumour DNA
DNA Methylation
Breast Cancer
Metastatic Breast Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kingston Health Sciences Centre - Cancer Centre of Southeastern Ontario
Address:
City:
Kingston
Zip:
K7L 5P9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Josee-Lyne Ethier, MD, M.Sc.
Phone:
613-544-2631
Phone ext:
4505
Email:
josee-lyne.ethier@kingstonhsc.ca
Facility:
Name:
The Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Arif Awan, MD
Phone:
613-737-7700
Phone ext:
70179
Email:
aawan@ohri.ca
Start date:
October 19, 2023
Completion date:
April 2026
Lead sponsor:
Agency:
Dr. Christopher Mueller
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (CIHR)
Agency class:
Other
Collaborator:
Agency:
Queen's University
Agency class:
Other
Source:
Queen's University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05804578
