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

• Conditions: Breast Neoplasms; Breast Cancer; Metastatic Breast Cancer; Cancer, Breast

• Registration Number: NCT04608357
• Lead Sponsor: Sunnybrook Health Sciences Centre

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).

Study Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Study Start: 2021-07-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada