Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
The investigators propose to use clinically validated patient avatar technology ("PDXovo") that can test multiple drugs against patients' cancers to identify the most promising systemic therapy for each individual.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18+.
Metastatic breast cancer irrespective of subtype.
Measurable disease as per RECIST 1.1 criteria.
Metastatic disease involving the lymph nodes and/or visceral organs is required.
Disqualifiers
Lack of feasibility to obtain a core biopsy of a metastatic site other than the bone (e.g. a metastatic lesion cannot be safely sampled due to proximity to vasculature).
Inability to provide informed consent.
Trial population
Patients with metastatic breast cancer irrespective of subtype prior to receiving either front-line or subsequent line systemic therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Needle Core Biopsies
Diagnostic testNot an interventional study
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Determine the tumor take rate in PDX
perform a feasibility study to determine the tumor take rate(s) in PDXs generated from needle core biopsies collected from metastatic breast cancer patients
Time frame
7-10 daysSecondary outcomes
1
Compare response rates of PDXs & with that of the patient from whom the PDX was derived
The response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate.
Time frame
8 to 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
AFP Innovation Fund
Collaborator
Source ClinicalTrials.gov