An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Neratinib
Followed by Weekly Paclitaxel and Carboplatin Plus Neratinib in Early Stage Triple-Negative
Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling
Transduction Analysis (FACT-2)
This is a prospective, single arm, open label, interventional study designed to evaluate the
efficacy of neoadjuvant chemotherapy with a pan-HER inhibitor in patients with
ER-/PR-/HER2-(triple-negative) invasive breast cancer who have abnormal HER2-driven signaling
activity determined by the Celcuity CELx HER2 signal function (HSF) test. Patients will be
required to have a prescreening research core needle biopsy to procure a fresh tumor specimen
that will be sent to Celcuity for CELx HSF testing, in order to assess the status of their
HER2-driven signaling activity (abnormally or normally active). While waiting for results of
the CELx HSF test, patients may receive the first dose of weekly paclitaxel at the
investigator's discretion. Patients whose CELx HSF test indicate they have abnormal
HER2-driven signaling activity will then receive neratinib as a single agent daily for 21
days and then neratinib plus paclitaxel and carboplatin.
The primary endpoint of the study is to evaluate whether patients with triple-negative breast
cancers (estrogen (ER) and progesterone (PR) receptors < 10%; HER2-negative per standard
ASCO/CAP testing criteria), but with abnormal HER2-driven signaling pathways determined by
the Celcuity CELx HSF assay, and who receive HER2-targeted therapy with neoadjuvant
chemotherapy will have a higher rate of pathological complete response (pCR) in the breast
and lymph nodes (pCR breast and lymph nodes) than has been found historically in patients
with triple-negative breast cancer who have received neoadjuvant chemotherapy. Secondary
endpoints include pathologic complete response (breast), clinical complete response (cCR),
residual cancer burden (RCB) 0-1 index, and relationship between quantitative CELx score and
It is expected that approximately 135 patients will need to be prescreened in order to enroll
27 patients who have abnormal HER2-driven signaling activity.
Breast Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, HER2 Positive Breast Cancer, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Early Stage Breast Cancer, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, her2/neu-positive breast cancer, her2-positive breast cancer
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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