Open label, comparative, randomised, multicentre study of trastuzumab given with docetaxel versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for Her2neu+++ metastatic breast cancer patients
| ISRCTN | ISRCTN13770586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13770586 |
| Secondary identifying numbers | NTR308 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/11/2008
- 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 J.G.M. Klijn
Scientific
Scientific
Erasmus Medical Centre
Daniel den Hoed Kliniek
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 439 1733 |
|---|---|
| j.g.m.klijn@erasmusmc.nl |
Study information
| Study design | Multicentre, open-label, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HERTAX, BOOG 2002-02 |
| Study objectives | Although combined treatment will probably lead to higher response rates, sequential treatment may result in a similar time to progression in the presence of less side effects and a better quality of life in a significant number of patients. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Arm A: combination of trastuzumab and docetaxel Arm B: trastuzumab followed by docetaxel Trastuzumab: Loading dose of 4 mg/kg intravenous (IV) on day 1, administered as 90-minute infusion, followed by a weekly dose of 2 mg/kg Docetaxel: TXT 100 mg/m2 IV infusion over one hour repeated in cycles, every 3 weeks for 6 cycles. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Trastuzumab, docetaxel |
| Primary outcome measure | Progression free survival of total sequential versus combined treatment. |
| Secondary outcome measures | Response rate and overall survival. |
| Overall study start date | 01/02/2003 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Histologically documented invasive adenocarcinoma of the breast 2. Women with previously chemotherapeutically untreated metastatic breast cancer with HER2neu over expression (defined as 3+ IHC by DAKO HercepTest) 3. Patients having previously received adjuvant treatment with an anthracycline/anthraquinone (maximum cumulative dose: doxorubicin 360 mg/m^2, epirubicin 750 mg/m^2 or equivalent dose of other anthracycline/anthraquinone) 4. Patients over the age of 18; Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 and life expectancy greater than 12 weeks 5. Patients with evaluable disease or patients having at least one measurable target outside previously irradiated field 6. Adequate bone marrow, hepatic and renal functions as evidenced by the following: 6.1. Haemoglobin greater than 6 mmol/l and no blood transfusion within the previous 2 weeks 6.2. White Blood Cell (WBC) count greater than 3.0 x 10^9 cells/l and neutrophils greater than 1.5 x 10^9 cells/l 6.3. Platelets count greater than 100 x 10^9 cells/l 6.4. No evidence of myelodysplastic syndrome or abnormal bone marrow reserve 6.5. Creatinine less than 1.5 upper normal limit (UNL) or creatinine clearance greater than 60 ml/min 6.6. Total bilirubin less than 1 x UNL 6.7. Aspartate aminotransferase (ASAT) (serum glutamic oxaloacetic transaminase [SGOT]) and/or alanine aminotransferase (ALAT) (serum glutamic pyruvic transaminase [SGPT]) less than 2.5 x UNL 6.8. Alkaline phosphatase less than 5 x UNL 6.9. ASAT and/or ALAT less than 1.5 x UNL in combination with elevated alkaline phosphatase less than 2.5 x UNL 7. Previous radiotherapy is allowed if end of radiotherapy (RT) more than 14 days prior to study entry, in case RT was given on relevant areas 8. Patient has fully recovered from all acute toxic effects 9. Normal cardiac function with left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) greater than 50% or within UNL of the institution 10. Written informed consent and accessible for treatment and follow up |
| Key exclusion criteria | 1. Operable local relapse alone after conservative treatment or contra-lateral tumour (mastitis or inoperable local recurrence is acceptable for inclusion) 2. Pregnant or lactating women (females of childbearing potential must use adequate contraception) 3. History or presence of brain or leptomeningeal metastases 4. Current peripheral neuropathy less than National Cancer Institute (NCI) grade 2 5. Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix 6. Other serious illness or medical conditions: cardiac insufficiency (New York Heart Association [NYHA] III or IV), myocardial infarction within previous 6 months, unstable angina pectoris, uncontrolled arrhythmia at time of inclusion 7. Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy 8. Clinically significant active infections 9. Poorly controlled diabetes mellitus 10. Uncontrolled hypertension 11. Active peptic ulcer or other contraindication to high dose of corticosteroid therapy such as herpes zoster, cirrhosis 12. History of allergy to drugs containing polysorbate 20, or the excipient TWEEN 80 13. Patient with a history of a psychological illness or condition such as to interfere with the patients ability to understand the requirements of the study 14. Patients who had received an investigational new drug within the last 30 days 15. Patients having received prior therapy with taxoids or anti-HER2 therapies |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Sponsor information
Breast Cancer Study Group (BOOG) (The Netherlands)
Research organisation
Research organisation
P.O. Box 9236
Amsterdam
1006 AE
Netherlands
| Phone | +31 (0)20 346 2547 |
|---|---|
| boog@ikca.nl | |
"ROR" |
https://ror.org/04cr37s66 |
Funders
Funder type
Industry
Roche Nederland BV (The Netherlands)
No information available
Sanofi-Aventis (The 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 |
