Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

Status unconfirmed · Phase 2

Conditions studied: Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer

In brief

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)

Key facts

Study ID

NCT03812393

Run by

West Cancer Center

People needed

27

Starts

2019-06-21

Expected to finish

2024-12-15

Last updated by the study team

2023-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and i institutional guidelines for the pre-entry research core biopsy for CELx HSF testing and for initiating chemotherapy
• Patients must be female.
• Patients must be ≥ 18 years old.
• Patient must have an ECOG performance status of 0 or 1
• The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
• The primary breast tumor must be palpable and measure ≥ 1.0 cm on physical exam.
• The regional lymph nodes can be cN0 or cN1
• The tumor size can be T1c or T2
• Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 6 weeks prior to initiating chemotherapy. If suspicious or abnormal, FNA or core biopsy is recommended, also within 6 weeks prior to initiating chemotherapy. Findings of these evaluations will be used to determine the nodal status prior to initiating chemotherapy.
• Nodal status - negative
• Imaging of the axilla is negative;
• Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative;
• Nodal status - positive
• FNA or core biopsy of the node(s) is cytologically or histologically suspicious or positive.
• Imaging is suspicious or abnormal but FNA or core biopsy was not performed.
• Tumor specimen obtained at the time of diagnosis must have estrogen (ER) and progesterone (PR) receptors < 10%.
• Tumor specimen obtained at the time of diagnosis must have been determined to be HER2-negative as follows:
• Immunohistochemistry (IHC) 0-1+; or
• IHC 2+ and ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or
• ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells.
• Blood counts performed within 6 weeks prior to initiating chemotherapy must meet the following criteria:
• Absolute neutrophil count (ANC) must be ≥ 1200/mm3;
• platelet count must be ≥ 100,000/mm3; and
• hemoglobin must be ≥ 10 g/dL.
• The following criteria for evidence of adequate hepatic function performed within 6 weeks prior to initiating chemotherapy must be met:

You may not qualify if…

• T3 or T4 tumors including inflammatory breast cancer.
• FNA alone to diagnose the breast cancer.
• Excisional biopsy or lumpectomy performed prior to initiating chemotherapy.
• Surgical axillary staging procedure prior to initiating chemotherapy. Pre- neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.)
• Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy.
• Synchronous bilateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
• Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
• Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies for any malignancy.
• Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to initiating chemotherapy.)
• History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 2 years prior to initiating chemotherapy.
• Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
• Active cardiac disease:
• angina pectoris that requires the use of anti-anginal medication;
• ventricular arrhythmias except for benign premature ventricular contractions;
• supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
• conduction abnormality requiring a pacemaker;
• valvular disease with documented compromise in cardiac function; and
• symptomatic pericarditis.
• History of cardiac disease:
• myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
• history of documented congestive heart failure (CHF); and
• documented cardiomyopathy.
• Uncontrolled hypertension defined as sustained systolic BP > 150 mmHg or diastolic BP > 90 mmHg. (Patients with initial BP elevations are eligible prior to initiating chemotherapy if initiation or adjustment of BP medication lowers pressure.)
• Active hepatitis B or hepatitis C with abnormal liver function tests.
• Intrinsic lung disease resulting in dyspnea.

Where it is running

• West Cancer Center — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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