Contact information
Type
Scientific
Primary contact
Prof J.G.M. Klijn
ORCID ID
Contact details
Erasmus Medical Centre
Daniel den Hoed Kliniek
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 439 1733
j.g.m.klijn@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR308
Study information
Scientific title
Acronym
HERTAX, BOOG 2002-02
Study hypothesis
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
Received from the local medical ethics committee
Study design
Multicentre, open-label, randomised, active controlled, parallel group trial
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: 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
Phase
Not Specified
Drug names
Trastuzumab, docetaxel
Primary outcome measures
Progression free survival of total sequential versus combined treatment.
Secondary outcome measures
Response rate and overall survival.
Overall trial start date
01/02/2003
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant 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
Recruitment start date
01/02/2003
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3008 AE
Netherlands
Sponsor information
Organisation
Breast Cancer Study Group (BOOG) (The Netherlands)
Sponsor details
P.O. Box 9236
Amsterdam
1006 AE
Netherlands
+31 (0)20 346 2547
boog@ikca.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Roche Nederland BV (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanofi-Aventis (The 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