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 measure
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 (if study stopped)
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
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
For-profit companies (industry)
Location
United States of America
Funder name
Pfizer (Netherlands)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list