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A Study of Trastuzumab-MCC-DM1 (T-DM1) in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression - NCT00943670-60099(Clinical Trial 385287)



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City:  Zion
State:  
IL
Zip Code: 60099
Conditions: Metastatic Breast Cancer
Purpose: This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and to make preliminary assessments regarding the safety, tolerability, and efficacy of combined T-DM1 and pertuzumab in patients with early disease progression. The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction.
Study summary:
Criteria: Inclusion Criteria: - Histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted - HER2-positive disease - History of prior trastuzumab therapy - Life expectancy ≥ 90 days as assessed by the investigator - Negative urine pregnancy test ≤ 72 hours prior to C1D1 for all women of childbearing potential - For patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of T-DM1 or 6 months after the last dose of pertuzumab, if applicable Exclusion Criteria: - Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment - Prior T-DM1 or pertuzumab therapy - History of intolerance (such as Grade 3-4 infusion reaction) and/or adverse events related to trastuzumab - Grade ≥ 2 (based on NCI CTCAE v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment - Brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to the first study treatment - History of cardiac disease, unstable angina, symptomatic CHF (Class ≥ II per the New York Heart Associate [NYHA] guidelines), myocardial infarction, or ventricular arrhythmia ≤ 6 months prior to Cycle 1, Day 1 - Implantable pacemaker or automatic implantable cardioverter defibrillator - Congenital long QT syndrome or family history of long QT syndrome - Current uncontrolled hypertension - Current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (TdP) - Current known active infection with HIV, hepatitis B virus, or hepatitis C virus - Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment
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Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
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