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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 May 2013 |
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Main ID: |
NCT00976989 |
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Date of registration:
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14/09/2009 |
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Primary sponsor: |
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Public title:
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A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Patients With HER2-Positive Breast Cancer
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Scientific title:
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Date of first enrolment:
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December 2009 |
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Target sample size:
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225 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00976989 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Bahamas
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Bosnia and Herzegovina
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Brazil
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Canada
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Croatia
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Germany
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Greece
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Italy
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Korea, Republic of
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Mexico
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New Zealand
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Portugal
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Romania
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Serbia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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United Kingdom
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- female patients, age >/=18 years
- advanced, inflammatory or early stage unilateral invasive breast cancer
- HER2-positive breast cancer
- baseline LVEF >/=55%
Exclusion Criteria:
- metastatic disease (Stage IV) or bilateral breast cancer
- previous anticancer therapy or radiotherapy for any malignancy
- other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma
- clinically relevant cardiovascular disease
- current chronic treatment with corticosteroids of >10mg methylprednisolone or
equivalent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: carboplatin
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Drug: docetaxel
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Drug: FEC: 5-Fluorouracil/epirubicin/cyclophosphamide
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Drug: pertuzumab
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Drug: trastuzumab
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Drug: trastuzumab [Herceptin]
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Primary Outcome(s)
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Tolerability during neoadjuvant treatment: symptomatic cardiac events, LVEF
[Time Frame: throughout cycles 1-6, complete cardiac questionnaire every 3 weeks, LVEF cycles 2, 4 and 6]
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Secondary Outcome(s)
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Clinical response rate, time to response, disease-free survival, progression-free survival, overall survival
[Time Frame: throughout study, tumour assessment/breast examination every 3 weeks]
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Pathological complete response rate
[Time Frame: at surgery, after 6 cycles of treatment]
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Safety: AEs, laboratory parameters, LVEF, ECG
[Time Frame: throughout study, laboratory parameters assessed every 3 weeks, LVEF and ECG every 2-3 cycles]
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Secondary ID(s)
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2009-012019-17
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BO22280
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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