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

What this Trial Is About

Researchers are evaluating the use of clinically validated patient avatar technology called "PDXovo" to test multiple drugs against metastatic breast cancer tumors. This study aims to identify the most promising systemic therapy for each patient by generating patient-derived xenografts (PDXs) and comparing their drug responses to the patient's clinical response. The primary goal is to determine the success rate of creating PDXs within 7 to 10 days, which could provide actionable treatment information if implemented in clinical practice. The study involves obtaining needle core biopsies from metastatic breast cancer sites before patients begin planned systemic therapy. These PDXs will receive the same drugs as the patient, allowing researchers to assess how well the PDX response matches the patient's response to treatment. The comparison will include measuring the objective response rate at 12 weeks, with a window of plus or minus 4 weeks, using RECIST 1.1 criteria. Participants will undergo biopsy procedures and have their disease measured using standardized criteria. Researchers will monitor tumor take rates in PDXs and compare responses to systemic therapy. The study collects data on metastatic involvement in lymph nodes or visceral organs and requires measurable disease. Safety and informed consent are ensured, with a focus on generating useful predictive information about treatment effectiveness. The timeline includes a primary outcome measurement within 7 to 10 days and response evaluation around 12 weeks.

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