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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608357
• Other study ID #: SUN-2252
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

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

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