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View Clinical Trial (Medical Research Study)
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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)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy385287.aspx
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| City: |
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Zion |
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State:
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IL |
| Zip Code: |
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60099 |
| Conditions: |
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Metastatic Breast Cancer |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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