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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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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN76560285 |
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Date of registration:
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19/04/2005 |
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Primary sponsor: |
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Public title:
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Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer
FinHer |
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Scientific title:
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Date of first enrolment:
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Nov 1 2000 |
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Target sample size:
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1010 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN76560285 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
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Countries of recruitment
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Finland
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Contacts
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Name:
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Heikki
Joensuu |
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Address:
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Department of Oncology
Helsinki University Central Hospital
Haartmaninkatu 8
FIN-00029
Helsinki
Finland |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically confirmed breast cancer
2. Age 65 or less
3. Progesterone receptor (PgR) and human epidermal growth factor receptor two (HER2) status available
4. M0
5. Written informed consent
6. Estimated risk of breast cancer recurrence more than 25% within the first five years from the diagnosis: pN+ or pN0 with tumor size more than 20 mm and PgR negative
Exclusion criteria: 1. Special type of histology without axillary lymph node metastases
2. World Health Organisation (WHO) performance status (PS) more than one
3. Blood leukocyte count less than 3.0 or granulocyte count less than 1.5, thrombocyte count less than 120
4. Severe cardiac disease or hypertension
5. Severe liver disease
6. Pregnancy
7. Male breast cancer
8. More than 12 weeks between breast surgery and study entry
9. Prior cancer except for basalioma/any in situ cancer
Age minimum:
Age maximum:
Gender:
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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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Randomisation:
1. Between weekly vinorelbine 25 mg/m^2 x 8 followed by cyclophosphamide, epirubicin and 5-fluorouracil (CEF) x 3 vs three weekly docetaxel 100 mg/m^2 x 3 followed by CEF x 3
2. Whenever tumor is HER2-positive, a second randomization between weekly trastuzumab 2 mg/kg concomitantly with vinorelbine/docetaxel versus no trastuzumab
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Primary Outcome(s)
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Disease-free survival
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Secondary Outcome(s)
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Survival, safety, quality of life, cardiac ejection fraction
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Secondary ID(s)
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FBCG 00-01
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Source(s) of Monetary Support
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Sponsored by the Finnish Breast Cancer Group; supported by Sanofi-Aventis, Pierre-Fabre, Pharmacia; HYKS Institute Project Number 2161
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