Using patient avatars to guide treatment for metastatic breast cancer
Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients
This study is testing whether using patient avatars made from biopsy samples can help find the best treatments for people with metastatic breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04608357 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using patient avatar technology, known as PDXovo, to identify effective systemic therapies for individuals with metastatic breast cancer. By generating patient-derived xenografts (PDXs) from biopsy samples, the study will assess how well these avatars respond to the same drugs administered to the patients. The primary goal is to determine the success rate of generating PDXs within 7-10 days, while a secondary goal involves comparing the PDX response to the patient's clinical response to therapy over a 12-week period. This approach could provide personalized treatment options based on individual tumor responses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with measurable metastatic breast cancer involving lymph nodes or visceral organs.
Not a fit: Patients who cannot safely undergo a core biopsy of a metastatic site or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with metastatic breast cancer.
How similar studies have performed: While the use of patient avatars in cancer treatment is an emerging field, similar studies have shown promise in personalizing therapy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Katarzyna J Jerzak, MD MSc FRCPC — Sunnybrook Health Sciences Centre
- Study coordinator: Katarzyna J Jerzak, MD MSc FRCPC
- Email: katarzyna.jerzak@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.