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

ConditionBreast Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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).

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).

Disqualifiers

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.

Evidence of metastatic breast cancer

ER and/or PR expression >10% on immunohistochemistry

Trial design

Design model

Parallel

Treatments tested in this trial

  • Functional Precision Oncology

    Other intervention

    Patient derived models (PDMs), comprising patient derived xenografts (PDXs) and organoids (PDO and PDxO),

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Treatment: All PatientsExperimental treatment 1 intervention
Group B: Physician QuestionnaireNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of cases where clinically actionable therapies were identified by FPO.

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

Time frame
up to 3 years
2

Compare the distant recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-)

Confirm that tumor engraftment as a PDX predicts early metastatic recurrence

Time frame
Data will be assessed at 1-year and 3-year endpoints from the time of definitive surgery.
3

Compare the recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-)

Confirm that tumor engraftment as a PDX predicts early metastatic recurrence

Time frame
Data will be assessed at 3-years from the time of definitive surgery.

Secondary outcomes

1

Correlation between tumor engraftment (PDX+/-) and relapse-free survival, overall survival, and response to preoperative chemotherapy and treatment response as assessed on the Residual Cancer Burden scale

assess the correlation between PDX establishment and other clinical outcomes

Time frame
up to 3 years
2

Proportion of cases where any type of patient derived models are successfully generated and clinically actionable therapies are identified by functional precision oncology.

assess additional measures of feasibility and utility of Functional Precision Oncology

Time frame
up to 3 years
3

Correlation between MHCII Immune Activation Score (high vs. low and as a continuous variable) and tumor engraftment (PDX+/-) and clinical outcomes (relapse-free and overall survival).

determine the correlation between MHCII immune activation score and PDX engraftment

Time frame
up to 3 years
4

Correlation between methylated ctDNA measurements as assessed using the MethylPatch assay pretreatment, pre- and post surgery, with PDX engraftment data (+/-) and clinical outcomes (relapse-free and overall survival)

determine if measurement of methylated ctDNA can strengthen predictions of recurrence when combined with PDX engraftment data

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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