Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof J.G.M. Klijn


Contact details

Erasmus Medical Centre
Daniel den Hoed Kliniek
Department of Medical Oncology
P.O. Box 5201
3008 AE
+31 (0)10 439 1733

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Breast cancer


Arm A: combination of trastuzumab and docetaxel
Arm B: trastuzumab followed by docetaxel

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

TXT 100 mg/m2 IV infusion over one hour repeated in cycles, every 3 weeks for 6 cycles.

Intervention type



Not Specified

Drug names

Trastuzumab, docetaxel

Primary outcome measure

Progression free survival of total sequential versus combined treatment.

Secondary outcome measures

Response rate and overall survival.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Erasmus Medical Centre
3008 AE

Sponsor information


Breast Cancer Study Group (BOOG) (The Netherlands)

Sponsor details

P.O. Box 9236
1006 AE
+31 (0)20 346 2547

Sponsor type

Research organisation



Funder type


Funder name

Roche Nederland BV (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Sanofi-Aventis (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes