Functional Precision Oncology for Triple-Negative Breast Cancer
This study is looking at a new approach called Functional Precision Oncology (FPO) to help predict, prevent, and treat the return of triple-negative breast cancer (TNBC) or hormone receptor-low/HER2-negative breast cancer. Researchers will create models from your tumor tissue, called patient-derived models (PDMs), including patient-derived xenografts (PDXs) and organoids (PDOs and PDxOs). These models will be used to understand your cancer better and test different treatments. The goal is to identify effective therapies if your cancer returns. The study aims to see how often FPO can find useful treatments and compare recurrence rates in patients whose tumors successfully grew in models versus those that didn't. About 80 people are expected to join this study. You may be eligible if you are 18 or older and have Stage I-III triple-negative or hormone receptor-low/HER2-negative breast cancer.
- Study design
- This is an interventional study planning to enroll 80 participants. It is a prospective phase 2 study.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your recurrence rates will be assessed at 1-year and 3-years from the time of definitive surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05464082
Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~80 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Functional Precision Oncology
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of cases where clinically actionable therapies were identified by FPO.
Measured over up to 3 years
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesUtah1
Study leadership
- Christos Vaklavas, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subject aged ≥ 18 years.
Subject has Stage I-III disease.
Histologically or cytologically confirmed invasive breast carcinoma that is triple negative (TNBC) or hormone receptor (HR)-low/Her2 negative
TNBC is defined as:
HER2 expression 0 or 1+ on immunohistochemistry (IHC) or non-amplified (defined as HER2/CEP17 ratio \<2 or copy number \<6) on fluorescence in situ hybridization (FISH). If HER2 expression is 2+ on IHC, non-amplified HER2 expression must be confirmed by FISH. Pathologic diagnosis of TNBC (negative HER2 status by cytogenetics, \<1% of cells stained positive for estrogen receptor (ER) by IHC, and \<1% of cells stained positive for progesterone receptor (PR) by IHC).
HR-low/Her2(-) is defined as:
HER2 expression 0 or 1+ on IHC or non-amplified (defined as HER2/CEP17 ratio \<2 or copy number \<6) on fluorescence in situ hybridization (FISH). If HER2 expression is 2+ on IHC, non-amplified HER2 expression must be confirmed by FISH.1-10% of cells stained positive for ER by IHC, and/or 1-10% of cells stained positive for PR by IHC).
Primary tumor OR local lymph node metastasis that is ≥ 1.5 cm. Patients with inflammatory breast cancer are eligible, regardless of tumor size. Patients with multifocal or multicentric breast cancer are eligible so long as ALL tumors biopsied per standard of care guidelines and/or investigator discretion meet receptor status criteria, and at least one tumor measures ≥ 1.5 cm.
Patient is considered for preoperative cytotoxic chemotherapy per standard of care or in the context of a separate, ongoing clinical trial.
Patient has not received any prior therapy for thier breast cancer.
Willing and capable (per treating investigator's assessment) to undergo baseline tumor material collection from the primary tumor or lymph node metastasis.
Patient can safely undergo tumor collection:
The tumor is reasonably accessible to tumor collection
The tumor is amenable to tumor collection (e.g. does not abut neurovascular structures)
If the patient receives anticoagulation, anticoagulation can be safely withheld to accommodate for tumor material acquisition
The patient does not have a medical condition that would render tumor acquisition a high-risk procedure (e.g. tumor material acquisition from lung metastases in a patient with emphysema)
Life expectancy of ≥ 12 months as assessed by the treating investigator.
ECOG Performance Status ≤ 2.
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have estradiol and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
No prior history of local or locally advanced hormone receptor positive (ER and/or PR expression \>10% on immunohistochemistry) breast cancer, unless the following conditions are met:
All treatment with curative intent has been completed, except adjuvant medical non-chemotherapy treatments (e.g. adjuvant endocrine therapy with any hormonal agent and/or CDK4/6 inhibitors), AND
An interval of ≥6 months has elapsed between completion of these treatments and histologic diagnosis of eligible breast cancer.
Willing and able to answer the physician questionnaires at the protocol required time points.
Willing and able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion
Evidence of metastatic breast cancer
ER and/or PR expression \>10% on immunohistochemistry
Her2(+) and/or Her2-amplified breast cancer. HER2 expression 3+ on IHC or amplified (defined as HER2/CEP17 ratio ≥2 or copy number \>6) on fluorescence in situ hybridization (FISH). If HER2 expression is 2+ on IHC, reflex FISH must be performed to determine eligibility.
Patient has bilateral breast cancer
Patient received any anti-cancer therapy or any investigational therapy prior to study entry and collection of tumor.
Treatment includes: neoadjuvant therapy, radiation therapy, chemotherapy, bisphosphonates for an indication other than osteopenia/osteoporosis, and/or hormonal therapy administered for the currently diagnosed primary breast cancer prior to study entry. Hormonal therapy for a prior diagnosis of a hormone receptor-positive breast cancer us allowed.
The diagnosis of another malignancy, unless the patient is considered disease-free for ≥5 years before study entry. Patients are eligible if diagnosed and treated for carcinoma in situ of the cervix, melanoma in situ, colon cancer in situ, ductal carcinoma in situ, and basal and/or squamous cell carcinoma of the skin, early stage papillary thyroid cancer, and other low risk malignancies per investigator discretion.
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (\> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.
Renal or liver disease that prohibits the patient from receiving at least single-agent full recommended dose chemotherapy.
Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
QTc prolongation defined as a QTcF \> 500 ms.
Known congenital long QT.
Left ventricular ejection fraction \< 55%.
Uncontrolled hypertension defined as ≥ 160/100 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.
Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[subjects may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
What this trial measures
- Proportion of cases where clinically actionable therapies were identified by FPO.up to 3 years
Assess the feasibility and utility of Functional Precision Oncology (FPO) testing to identify therapies for patients with TNBC or HR-low/HER2- breast cancer who are at high risk of early recurrence
- Compare the distant recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-)Data will be assessed at 1-year and 3-year endpoints from the time of definitive surgery.
Confirm that tumor engraftment as a PDX predicts early metastatic recurrence
- Compare the recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-)Data will be assessed at 3-years from the time of definitive surgery.
Confirm that tumor engraftment as a PDX predicts early metastatic recurrence