Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05464082

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

Led by University of Utah · Updated on 2026-02-20

80

Participants Needed

1

Research Sites

299 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Stage I-III invasive breast carcinoma confirmed as triple negative or hormone receptor-low/Her2 negative
  • Primary tumor or local lymph node metastasis measuring at least 1.5 cm
  • Considered for preoperative chemotherapy per standard care or clinical trial
  • No prior therapy for current breast cancer
  • Able and willing to undergo tumor material collection safely
  • Life expectancy of 12 months or more
  • ECOG Performance Status 0 to 2
  • For females, post-menopausal status or negative pregnancy test if pre-menopausal
  • Able to provide informed consent
  • No prior local hormone receptor positive breast cancer unless treated and 6 months have passed since treatment
Not Eligible

You will not qualify if you...

  • Evidence of metastatic breast cancer
  • Estrogen or progesterone receptor expression greater than 10%
  • Her2 positive or Her2 amplified breast cancer
  • Bilateral breast cancer
  • Prior anti-cancer or investigational therapy before tumor collection
  • Diagnosis of another malignancy unless disease-free for 5 years (exceptions apply)
  • Uncontrolled significant illness including recent serious heart or vascular events
  • Severe cardiac conditions or QTc prolongation
  • Left ventricular ejection fraction below 55%
  • Uncontrolled hypertension (160/100 or higher)
  • Any condition that in the investigator's opinion contraindicates participation
  • Medical, psychiatric, cognitive, or other conditions impairing consent or compliance

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

J

Janna Espinosa

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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