Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Needle Core Biopsies.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Neoplasms, Metastatic Breast Cancer, Cancer, Breast. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients
Overview
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).
Interventions
- Diagnostic test Needle Core Biopsies
Not an interventional study
Primary outcome measures
- Determine the tumor take rate in PDX [Time frame: 7-10 days]
Secondary outcome measures (1)
- Compare response rates of PDXs & with that of the patient from whom the PDX was derived [Time frame: 8 to 16 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Publications
- Grafinger OR, Hayward JJ, Meng Y, Geddes-McAlister J, Li Y, Mar S, Sheng M, Su B, Thillainadesan G, Lipsman N, Coppolino MG, Trant JF, Jerzak KJ, Leong HS. Cancer cell extravasation requires iplectin-mediated delivery of MT1-MMP at invadopodia. Br J Cancer. 2024 Sep;131(5):931-943. doi: 10.1038/s41416-024-02782-9. Epub 2024 Jul 5. PMID 38969866
Identifiers
NCT: NCT04608357 · SUN-2252