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View Clinical Trial (Medical Research Study)
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A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer (CLEOPATRA) - NCT00567190-60099 (Clinical Trial 192864)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy192864.aspx
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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 study is a Phase III, randomized, double-blind, placebo-controlled, multicenter
international clinical trial. Patients who have HER2-positive MBC and have not received
chemotherapy or biologic therapy (including approved or investigational tyrosine kinase/ HER
inhibitors or vaccines) for their metastatic disease are eligible for study. Patients could
have received one prior hormonal treatment for MBC. Patients may have received systemic
breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the patient
has experienced a DFI of ≥ 12 months from completion of adjuvant systemic treatment
(excluding hormonal therapy) to metastatic diagnosis. Patients may have received trastuzumab
and/or a taxane during the neo-adjuvant or adjuvant treatment.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
recurrent or metastatic disease, and candidate for chemotherapy. Patients with
measurable and non-measurable disease are eligible (locally recurrent disease must
not be amenable to resection with curative intent; patients with de-novo Stage IV
disease are eligible)
- HER2-positive metastatic breast cancer (MBC)
- Age ≥ 18 years
- Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline (within 42 days of
randomization)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- For women of childbearing potential, agreement to use an effective form of
contraception and to continue its use for the duration of study treatment and for 6
months after the last dose of study treatment
- Signed, written informed consent obtained prior to any study procedure
Exclusion Criteria:
- History of anticancer therapy for MBC (with the exception of one prior hormonal
regimen for MBC)
- History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer
in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant
setting
- History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting
with a disease-free interval from completion of the systemic treatment (excluding
hormonal therapy) to metastatic diagnosis of < 12 months
- History of persistent Grade ≥ 2 hematologic toxicity resulting from previous adjuvant
therapy
- Current peripheral neuropathy of NCI-CTCAE, Version 3.0, Grade ≥ 3 at randomization
- History of other malignancy within the last 5 years, except for carcinoma in situ of
the cervix or basal cell carcinoma
- Current clinical or radiographic evidence of central nervous system (CNS) metastases
- CT or MRI scan of the brain is mandatory in cases of clinical suspicion of brain
metastases
- History of exposure to cumulative doses of anthracyclines
- Current uncontrolled hypertension or unstable angina
- History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac
arrhythmia requiring treatment
- History of myocardial infarction within 6 months of randomization
- History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant
or adjuvant therapy
- Current dyspnea at rest due to complications of advanced malignancy, or other
diseases that require continuous oxygen therapy
- Inadequate organ function within 28 days prior to randomization
- Current severe, uncontrolled systemic disease
- Major surgical procedure or significant traumatic injury within 28 days prior to
study treatment start or anticipation of the need for major surgery during the course
of study treatment
- Pregnant or lactating women
- History of receiving any investigational treatment within 28 days of randomization
- Current known infection with HIV, HBV, or HCV
- Receipt of IV antibiotics for infection within 14 days of randomization
- Current chronic daily treatment with corticosteroids (excluding inhaled steroids)
- Known hypersensitivity to any of the study drugs
- Assessed by the investigator to be unable or unwilling to comply with the
requirements of the protocol |
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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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