NCT04608357

Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients

Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer
• Cancer, Breast

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Needle Core Biopsies	Not an interventional study

Timeline

• Start date: 2021-07-21
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2020-10-29
• Last updated: 2025-01-20

Locations

1 site across 1 country: Canada