Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/07/2009
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 E. Boven

ORCID ID

Contact details

VU University Medical Center
Department of Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR472

Study information

Scientific title

Acronym

ETN study

Study hypothesis

Primary objectives: To assess the efficacy in terms of response rate of the combinations Epirubicin and Taxotere (ET), Taxotere and Navelbine (TN) and Navelbine and Epiribicin (EN).
Secondary objectives: To determine progression free survival and toxicity profiles.

Ethics approval

Received from the local media ethics committee

Study design

multicentre, randomised, active controlled, parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

Arm A: Epirubicin 75 mg/m2, day 1 and docetaxel 60 mg/m2 day 1
Arm B: Vinorelbine 20 mg/m2 day 1 + 8 and docetaxel 60 mg/m2 day 8 (closed January 2003)
Arm C: Epirubicin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 days 1 and 8.
One course consists of 21 days. Cycle is repeated every 3 weeks, for a maximum of 6 cycles.

Intervention type

Drug

Phase

Phase II/III

Drug names

epirubicin, docetaxel (Taxotere®), vinorelbine (Navelbine®)

Primary outcome measures

1. Time to progression
2. Response rate

Secondary outcome measures

1. Toxicity profile
2. Feasibility

Overall trial start date

01/04/2001

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven breast cancer at first diagnosis. At study entry histological or cytological proof of metastasis is required in case of a single metastatic target lesion.
2. Female metastatic breast cancer patients
3. Measurable disease or evaluable disease (bone metastases only allowed)
4. Previous chemotherapy: Adjuvant: Patients may have had adjuvant and/or neoadjuvant chemotherapy but no more than 240 mg/m2 cumulative dose of prior doxorubicin or no more than 450 mg/m2 of epirubicin. Taxanes in adjuvant setting are allowed. However, there must be at least 12 months interval between the end of (neo-)adjuvant chemotherapy and protocol entry. This interval is not required for patients who received non-anthracycline/non-taxane adjuvant and/or neoadjuvant chemotherapy. No previous chemotherapy for metastatic breast cancer is allowed.
5. Previous hormonal treatment: Previous hormonal treatment is allowed provided discontinuation >4 weeks before start of study treatment
6. Previous radiation: Previous radiation therapy may have been given provided it is not the only site to assess response
7. Age >18 and <70 years
8. WHO performance status 0, 1 or 2
9. Laboratory requirements:
a. Hematology: White blood cell count >3.0 x 10^9/l (if WBC <3.0 x 10^9/l, Neutrophils should be >1.5 x 10^9/l), Platelets >100 x 10^9/l, Hemoglobin >10 g/dl (>6.2 mmol/l)
b. Hepatic function: Total bilirubin <1.00 times the upper-normal limits (UNL) of the institutional normal values. ASAT (SGOT) and/or ALAT (SGPT) <2.5 UNL, alkaline phosphatase <5 UNL (unless bone metastasis are present in the absence of any liver disorders). NB: Patients with ASAT and/or ALAT >1.5 UNL associated with alkaline phosphatase >2.5 UNL are not eligible for study.
c. Renal function: Serum creatinine <80 umol/l. If serum creatinine >80 umol/l, calculated creatinine clearance (Cockroft Gould) should be >60 ml/min
10. Normal left ventricular ejection fraction (LVEF) or superior to the lower limits of the institution (determined by either MUGA scan or ultrasound methods)
11. Patients must be accessible for treatment and follow-up
12. Measurability of the disease and evaluation of response according to RECIST criteria
13. Complete initial work-up within 3 weeks prior to first infusion
14. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

111

Participant exclusion criteria

1. Prior chemotherapy for metastatic disease
2. Locally advanced inoperable breast cancer (Stage III B) as only manifestation of the disease
3. Non-measurable disease
4. Pregnant or lactating women or women of childbearing potential not using adequate contraception
5. History of prior malignancies (other than non melanoma skin cancer or excised cervical carcinoma in situ)
6. Clinical evidence of cerebral metastasis
7. Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Toxicity Criteria
8. WHO PS >2
9. Concurrent treatment with other experimental drugs
10. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
11. Concurrent treatment with any other anti-cancer therapy except for concomitant treatment with bisphosphonates, provided that bone metastases are not the only evaluable lesions for response to therapy (see measurability of disease and evaluation of response)

Recruitment start date

01/04/2001

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Center (Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Amgen (Netherlands)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Pfizer (Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Pierre Fabre (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanofi-Aventis (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

VU University Medical Center (Netherlands)

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

Publication citations

Additional files

Editorial Notes