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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms; Metastatic Breast Cancer; Cancer, Breast
• Intervention / Treatment: Diagnostic test: Needle Core Biopsies

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).

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Katarzyna J Jerzak, MD MSc FRCPC; Phone Number: 5248 416-480-6100; Email: katarzyna.jerzak@sunnybrook.ca
• Study Contact Backup: Name: Hon S Leong; Phone Number: 5748 416-480-6100; Email: hon.leong@sri.utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Katarzyna J Jerzak, MD MSc FRCPC; Phone Number: 5248 416-480-6100; Email: katarzyna.jerzak@sunnybrook.ca
      • Contact: Hon S Leong; Phone Number: 5748 416-480-6100; Email: hon.leong@sri.utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with metastatic breast cancer irrespective of subtype prior to receiving either front-line or subsequent line systemic therapy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: AFP Innovation Fund
• Investigators: Principal Investigator: Katarzyna J Jerzak, MD MSc FRCPC, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: feasibility study; metastatic breast cancer; systemic therapy; needle core biopsy; PDXovo; tumor take rate
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SUN-2252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No