Three arm randomized parallel phase II/III study evaluating the efficacy and safety of the combinations Epirubicin and Taxotere® (ET), Taxotere® and Navelbine® (TN) and Navelbine® and Epirubicin (EN) as first line therapy in patients with metastatic breast cancer
| ISRCTN | ISRCTN33132357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33132357 |
| Secondary identifying numbers | NTR472 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof E. Boven
Scientific
Scientific
VU University Medical Center
Department of Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Study information
| Study design | multicentre, randomised, active controlled, parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ETN study |
| Study objectives | 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(s) | Received from the local media ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | epirubicin, docetaxel (Taxotere®), vinorelbine (Navelbine®) |
| Primary outcome measure | 1. Time to progression 2. Response rate |
| Secondary outcome measures | 1. Toxicity profile 2. Feasibility |
| Overall study start date | 01/04/2001 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 111 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/04/2001 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
VU University Medical Center (Netherlands)
Not defined
Not defined
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
"ROR" |
https://ror.org/00q6h8f30 |
|---|
Funders
Funder type
Industry
Amgen (Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Pfizer (Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Pierre Fabre (France)
No information available
Sanofi-Aventis (France)
No information available
VU University Medical Center (Netherlands)
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 |
