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Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer
ISRCTN ISRCTN76560285
DOI 10.1186/ISRCTN76560285
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer
Scientific title
Acronym FinHer
Serial number at source FBCG 00-01
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Finland
Disease/condition/study domain Breast cancer
Participants - 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
Participants - 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
Anticipated start date 01/11/2000
Anticipated end date 31/08/2003
Status of trial Completed
Patient information material
Target number of participants 1010
Interventions 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
Primary outcome measure(s) Disease-free survival
Secondary outcome measure(s) Survival, safety, quality of life, cardiac ejection fraction
Sources of funding Sponsored by the Finnish Breast Cancer Group; supported by Sanofi-Aventis, Pierre-Fabre, Pharmacia; HYKS Institute Project Number 2161
Trial website
Publications 1. 2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16495393
2. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19884557
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24608200
Contact name Prof  Heikki  Joensuu
  Address Department of Oncology
Helsinki University Central Hospital
Haartmaninkatu 8
  City/town Helsinki
  Zip/Postcode FIN-00029
  Country Finland
Sponsor Finnish Breast Cancer Group, HYKS Institute
  Address HYKS-Institute
Haartmaninkatu 8
P.O. Box 700
  City/town Helsinki
  Zip/Postcode FIN-00029
  Country Finland
  Sponsor website: http://www.hus.fi
Date applied 18/03/2005
Last edited 18/03/2014
Date ISRCTN assigned 19/04/2005
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