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

Study Overview
=================
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).

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

Conditions
-----------------
Breast Cancer, Breast Neoplasms, Metastatic Breast Cancer, Cancer, Breast

Intervention / Treatment
-----------------
* Diagnostic Test: Needle Core Biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18+. Metastatic breast cancer irrespective of subtype. Measurable disease as per RECIST 1.1 criteria. Metastatic disease involving the lymph nodes and/or visceral organs is required. Willingness to undergo a biopsy prior to the start of planned systemic therapy. Exclusion Criteria: 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). Inability to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Needle Core Biopsies|Not an interventional study|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic breast cancer, systemic therapy, needle core biopsy, PDXovo, feasibility study, tumor take rate