Breast Cancer, Breast Neoplasms, Cancer, Breast, Metastatic Breast Cancer
Conditions
Keywords
metastatic breast cancer, systemic therapy, needle core biopsy, PDXovo, feasibility study, tumor take rate
Brief summary
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.
Detailed description
The primary goal of this feasibility study is to determine the percentage of patients for whom PDXs are successfully generated within 7-10 days. This will give the investigators an indication of the success rate for providing patients with actionable information if this PDX technology were to be implemented in the clinic. Since the PDXs will also receive the same drug as the patient, there is an opportunity to assess the agreement between the clinical response and the PDX response. As a secondary goal, the response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate at 12 weeks +/- 4 weeks (ORR, measured using RECIST 1.1 criteria).
Interventions
DIAGNOSTIC_TESTNeedle Core Biopsies
Not an interventional study
Sponsors
AFP Innovation Fund
Sunnybrook Health Sciences Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18+. 2. Metastatic breast cancer irrespective of subtype. 3. Measurable disease as per RECIST 1.1 criteria. 4. Metastatic disease involving the lymph nodes and/or visceral organs is required. 5. Willingness to undergo a biopsy prior to the start of planned systemic therapy.
Exclusion criteria
1. 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). 2. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the tumor take rate in PDX | 7-10 days | perform a feasibility study to determine the tumor take rate(s) in PDXs generated from needle core biopsies collected from metastatic breast cancer patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare response rates of PDXs & with that of the patient from whom the PDX was derived | 8 to 16 weeks | The response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate. |
Countries
Canada
Contacts
Primary ContactKatarzyna J Jerzak, MD MSc FRCPC
Backup ContactHon S Leong
Outcome results
None listed