Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes