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ISRCTN
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ISRCTN76560285
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ClinicalTrials.gov identifier
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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
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Scientific title
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Acronym
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FinHer
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Serial number at source
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FBCG 00-01
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Study hypothesis
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The purpose of the trial is to compare tolerability, safety and efficacy of single-agent vinorelbine and single-agent docetaxel as adjuvant treatments of early breast cancer with moderate to high risk for cancer recurrence. The trial also assesses tolerability, safety and efficacy of trastuzumab given concomitantly with vinorelbine or docetaxel as adjuvant treatment of early breast cancer with moderate to high risk for cancer recurrence.
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Ethics approval
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Not provided at time of registration
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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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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2000
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Anticipated end date
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31/08/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1010
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Interventions
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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 measure(s)
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Disease-free survival
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Secondary outcome measure(s)
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Survival, safety, quality of life, cardiac ejection fraction
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Sources of funding
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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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Trial website
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16495393
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19884557
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Contact name
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Prof
Heikki
Joensuu
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Address
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Department of Oncology
Helsinki University Central Hospital
Haartmaninkatu 8
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City/town
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Helsinki
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Zip/Postcode
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FIN-00029
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Country
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Finland
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Sponsor
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Finnish Breast Cancer Group, HYKS Institute
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Address
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HYKS-Institute
Haartmaninkatu 8
P.O. Box 700
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City/town
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Helsinki
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Zip/Postcode
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FIN-00029
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Country
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Finland
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Sponsor website:
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http://www.hus.fi
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Date applied
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18/03/2005
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Last edited
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30/11/2009
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Date ISRCTN assigned
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19/04/2005
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