Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer
- Conditions
- Breast cancerCancerBreast
- Registration Number
- ISRCTN76560285
- Lead Sponsor
- Finnish Breast Cancer Group, HYKS Institute
- Brief Summary
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 4. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29482642 5. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29535130 (added 20/11/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1010
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method Survival, safety, quality of life, cardiac ejection fraction