A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus Capecitabine for the Treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer - Not available

Wyeth Pharmaceuticals Inc., acting through its division Wyeth research, a Pfizer company0 sites230 target enrollmentJanuary 29, 2009

Conditionsocally advanced or metastatic breast cancer MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer

DrugsXELODA TYVERB

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ocally advanced or metastatic breast cancer
Sponsor: Wyeth Pharmaceuticals Inc., acting through its division Wyeth research, a Pfizer company
Enrollment: 230
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 29, 2009

End Date

December 19, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Wyeth Pharmaceuticals Inc., acting through its division Wyeth research, a Pfizer company

Eligibility Criteria

Inclusion Criteria

•1\. Women aged at least 18 years.
•2\. Histologically and/or cytologically confirmed diagnosis of breast cancer.
•3\. Locally advanced or metastatic breast cancer that is not amenable to curative surgery and/or radiation (stage IIIB, IIIC, or IV).
•4\. Documentation of erbB\-2 gene amplification by fluorescence in situ hybridization (FISH, as defined by a ratio \>2\.2\) or chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit instruction) or documentation of erbB\-2 overexpression by immunohistochemistry (IHC, defined as IHC3\+, or IHC2\+ with FISH or CISH confirmation) based on local laboratory or initial diagnostic results utilizing one of the sponsor\-approved assays. If erbB\-2 status was determined using a test other than a sponsor\-approved assay as defined in attachment 1, testing and study eligibility must be obtained from the sponsor\-identified central laboratory prior to randomization.
•5\. All subjects must have tumor tissue available for central review of erbB\-2 expression levels by FISH testing performed by the sponsor\-identified central laboratory.
•6\. Disease progression on or following a prior trastuzumab\-containing treatment regimen (regimen should have been given for a duration of at least 6 weeks), alone or in combination with cytotoxic chemotherapy or hormonal therapy for metastatic or locally advanced disease. A 2 week washout period is required between trastuzumab treatment and first dose of the investigational product.
•7\. Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment settings.
•8\. At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (specifically, ascites, pleural or pericardial effusion, osteoblastic bone metastases, and carcinomatous lymphangitis of the lung will not be considered measurable lesions). Subjects with skin lesions that are measurable by Computed Tomography (CT) scans or Magnetic Resonance Imaging (MRI) as the only site of measurable disease are allowed.
•9\. Eastern Cooperative Oncology Group (ECOG) status of 0,1 or 2 (not declining within 2 weeks prior to signing of informed consent).
•10\. Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by multiple\-gated acquisition (MUGA) or echocardiogram (ECHO).

Exclusion Criteria

•1\. More than 2 prior trastuzumab\-based regimens for metastatic or locally advanced disease.
•2\. Subjects with prior exposure to capecitabine, lapatinib, or other erbB\-2 targeted treatments (with the exception of trastuzumab).
•3\. Prior treatment with anthracyclines with a cumulative dose of doxorubicin of \> 400 mg/m2 or epirubicin dose \> 800 mg/m2, or the equivalent dose for other anthracycline derivatives.
•4\. Subjects with bone as the only site of disease.
•5\. Active uncontrolled or symtomatic CNS metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if the CNS lesions metastases have been treated with radiation and/or surgical resection and are off anticonvulsivants and steroids for at least 4 weeks before the first dose of investigational product.
•6\. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn disease, malabsorption, or grade \=2 diarrhea of any etiology at baseline).
•7\. Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association \[NYHA] functional classification of \=3\), unstable angina, or myocardial infarction.
•8\. Family history of long or short QT syndrome, Brugada syndrome or subjects with QT/QTc interval \> 0\.45 second or known history of QT/QTc prolongation or torsade de pointes (TdP).
•9\. Renal insufficiency defined as creatinine clearance \< 50 mL/min (as calculated by Cockroft and Gault Method).
•10\. History of known hypersensitivity to lapatinib, capecitabine, 5\-fluorouracil, or any of their excipients, or known dihydropyrimidine dehydrogenase deficiency.