Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast (FACT-2)
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|ClinicalTrials.gov Identifier: NCT03812393|
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : October 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer Early-stage Breast Cancer HER2-positive Breast Cancer||Drug: Neratinib||Phase 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 pCR rate.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single-arm interventional clinical trial with an early check for futility using a surrogate endpoint|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)|
|Actual Study Start Date :||June 21, 2019|
|Estimated Primary Completion Date :||October 15, 2020|
|Estimated Study Completion Date :||April 15, 2023|
TNBC patients with HER2 signal positive are treated with neratinib for 3 weeks followed by 12 weeks of neratinib in combination with weekly paclitaxel and carboplatin
For cycle 1 subjects will receive Neratinib 240mg daily for 21 days. For cycle 2-5, subjects will receive carboplatin AUC of 1.5 and Paclitaxel 80mg/m2 on day one in combination with Neratinib 240mg daily for 21 day.
Other Name: Live Cell HER2 signaling Transduction Analysis (CELx)
- The percentage of patients experiencing ≥ 20% response to neratinib only therapy [ Time Frame: 4 weeks ]patient with HER2 positive signal by CELx will be exposed to neratinib to determine response to HER2 therapy
- rate of pathologic complete response (pCR) [ Time Frame: 15 weeks ]percentage of patients with no tumor in breast at surgery following study treatment
- Clinical complete response (cCR) [ Time Frame: 15 weeks ]Endpoint Definition: Percentage of patients with clinical complete response rate based on physical examination of the breast and axilla.
- Residual cancer burden (RCB) 0-1 [ Time Frame: 15 weeks ]The measure of the amount of tumor left in breast at surgery following study treatment
- The PCR rate in patients experiencing greater than or equal to 20% reduction in tumor volume following treatment with neratinib only in cycle 1. [ Time Frame: 15 weeks ]To determine whether a significant decrease in size of tumor can predict whether the rate of complete tumor killing at surgery following study treatment
- Safety and Toxicity per NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). [ Time Frame: 15 weeks ]Measure whether the study treatment is safe and tolerable
- Increase in the number of patients completing neratinib prescription with the use of web based symptom monitoring [ Time Frame: 15 weeks ]See whether mobile application that connects patient at home to treatment team could increase patients ability to complete drug treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812393
|Contact: Gregory A Vidal, MD, Ph.D||9016830055 ext email@example.com|
|United States, Tennessee|
|West Cancer Center||Recruiting|
|Germantown, Tennessee, United States, 38139|
|Contact: Gregory A Vidal, MD/PhD 901-683-0055 ext 61242 firstname.lastname@example.org|
|Contact: Curry Luttrell, BS 9016830055 ext 63014 email@example.com|
|Principal Investigator: Gregory A Vidal, MD/PhD|
|Sub-Investigator: Surekha Joshi, MD|
|Sub-Investigator: Ilana Greatz, PhD|
|Principal Investigator:||Gregory A Vidal, MD.,PhD||West Cancer Center|