Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer
| ISRCTN | ISRCTN76560285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76560285 |
| Secondary identifying numbers | FBCG 00-01 |
- Submission date
- 18/03/2005
- Registration date
- 19/04/2005
- Last edited
- 20/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Heikki Joensuu
Scientific
Scientific
Department of Oncology
Helsinki University Central Hospital
Haartmaninkatu 8
Helsinki
FIN-00029
Finland
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer |
| Study acronym | FinHer |
| 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. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Breast cancer |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Vinorelbine, docetaxel, and trastuzumab |
| Primary outcome measure | Disease-free survival |
| Secondary outcome measures | Survival, safety, quality of life, cardiac ejection fraction |
| Overall study start date | 01/11/2000 |
| Overall study end date | 31/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1010 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/11/2000 |
| Recruitment end date | 31/08/2003 |
Locations
Countries of recruitment
- Finland
Study participating centre
Department of Oncology
Helsinki
FIN-00029
Finland
FIN-00029
Finland
Sponsor information
Finnish Breast Cancer Group, HYKS Institute
Charity
Charity
HYKS-Institute
Haartmaninkatu 8
P.O. Box 700
Helsinki
FIN-00029
Finland
| Website | http://www.hus.fi |
|---|---|
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Charity
Sponsored by the Finnish Breast Cancer Group; supported by Sanofi-Aventis, Pierre-Fabre, Pharmacia; HYKS Institute Project Number 2161
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/02/2006 | Yes | No | |
| Results article | results | 01/12/2009 | Yes | No | |
| Results article | results | 01/08/2014 | Yes | No | |
| Results article | results | 26/02/2018 | Yes | No | |
| Results article | results | 01/07/2018 | 20/11/2019 | Yes | No |
Editorial Notes
20/11/2019: Publication reference added.
25/03/2019: Publication reference added.
