Condition category
Cancer
Date applied
18/03/2005
Date assigned
19/04/2005
Last edited
18/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Heikki Joensuu

ORCID ID

Contact details

Department of Oncology
Helsinki University Central Hospital
Haartmaninkatu 8
Helsinki
FIN-00029
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FBCG 00-01

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Vinorelbine, docetaxel, and trastuzumab

Primary outcome measures

Disease-free survival

Secondary outcome measures

Survival, safety, quality of life, cardiac ejection fraction

Overall trial start date

01/11/2000

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

1010

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

Trial participating centre

Department of Oncology
Helsinki
FIN-00029
Finland

Sponsor information

Organisation

Finnish Breast Cancer Group, HYKS Institute

Sponsor details

HYKS-Institute
Haartmaninkatu 8
P.O. Box 700
Helsinki
FIN-00029
Finland

Sponsor type

Charity

Website

http://www.hus.fi

Funders

Funder type

Charity

Funder name

Sponsored by the Finnish Breast Cancer Group; supported by Sanofi-Aventis, Pierre-Fabre, Pharmacia; HYKS Institute Project Number 2161

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication 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

Publication citations

  1. Results

    Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkiö S, Flander M, Helle L, Ingalsuo S, Johansson K, Jääskeläinen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J, , Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer., N. Engl. J. Med., 2006, 354, 8, 809-820, doi: 10.1056/NEJMoa053028.

  2. Results

    Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, Utriainen T, Turpeenniemi-Hujanen T, Jyrkkiö S, Möykkynen K, Helle L, Ingalsuo S, Pajunen M, Huusko M, Salminen T, Auvinen P, Leinonen H, Leinonen M, Isola J, Kellokumpu-Lehtinen PL, Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial., J. Clin. Oncol., 2009, 27, 34, 5685-5692, doi: 10.1200/JCO.2008.21.4577.

  3. Results

    Loi S, Michiels S, Salgado R, Sirtaine N, Jose V, Fumagalli D, Kellokumpu-Lehtinen PL, Bono P, Kataja V, Desmedt C, Piccart MJ, Loibl S, Denkert C, Smyth MJ, Joensuu H, Sotiriou C, Tumor infiltrating lymphocytes are prognostic in triple negative breast cancer and predictive for trastuzumab benefit in early breast cancer: results from the FinHER trial., Ann. Oncol., 2014, 25, 8, 1544-1550, doi: 10.1093/annonc/mdu112.

Additional files

Editorial Notes