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
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
Treatments tested in this trial
- Functional Precision Oncology
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Utah
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov