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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04608357
Other study ID # SUN-2252
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 21, 2021
Est. completion date December 2023

Study information

Verified date October 2021
Source Sunnybrook Health Sciences Centre
Contact Katarzyna J Jerzak, MD MSc FRCPC
Phone 416-480-6100
Email katarzyna.jerzak@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Needle Core Biopsies
Not an interventional study

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre AFP Innovation Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 7-10 days
Secondary 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. 8 to 16 weeks
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