Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05464082
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Functional Precision Oncology — OTHER
    Patient derived models (PDMs), comprising patient derived xenografts (PDXs) and organoids (PDO and PDxO),

Study Details

This is a prospective phase 2 study to use Functional Precision Oncology (FPO) to predict, prevent and treat early metastatic recurrence in subjects with HR-low/Her2 negative or triple negative breast cancer.

Key Dates

Start date
Jan 6, 2023
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment: All Patients
    Patient derived xenografts (PDX) are grown in mice. Organoids may generated from patient tumor(PDO) and PDX(PDxO). Organoids will be used for drug profiling. PDX, organoid establishment and drug profiling will occur while patient is undergoing preoperative chemo, surgery, radiation, and may extend into disease-free interval. Patients receive first line therapy in the metastatic setting per SOC or in separate clinical trial. Results of PDM drug profiling, tumor genomic, and circulating tumor DNA results will be returned to treating physician to inform 2nd line therapy. At progression on the first line therapy, the patient will begin new therapy as directed by the treating physician. Any subsequent therapy (aligned or unaligned with report recommendations) that a patient starts after the return of results will be deemed "informed".
  • No Intervention: Physician Questionnaire
    Prior to the return of results, treating physicians will be asked to complete the PRE-Information Provider Survey on Functional Precision Oncology. After review of the FPO results, treating physicians will be asked to complete the POST-Information Provider Survey on Functional Precision Oncology to assess the potential effect that the FPO results have on the selection of therapy. These surveys will be administered to assess the impact the results have on the selection of therapy. Physicians are not mandated to select the treatment recommended by the FPO data since the FPO results are not from a CLIA certified laboratory. Information regarding whether the physician chose to switch to the recommended drug or not for the next line of therapy and patient outcomes (progression-free survival) according to treatment selection (treatment selected aligned with FPO recommendation vs. not) will be captured.

Primary Outcome Measure

Proportion of cases where clinically actionable therapies were identified by FPO. [ Time Frame: up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at University of UtahSalt Lake CityUtah84112
Janna Espinosa
[email protected]
801-585-0571

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By research site
Huntsman Cancer Institute at University of Utah· Salt Lake City, UT

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