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Open label, comparative, randomized, multicenter, 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.


- candidate number1504
- NTR NumberNTR308
- ISRCTNISRCTN13770586
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleOpen label, comparative, randomized, multicenter, 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.
- Scientific TitleOpen label, comparative, randomized, multicenter, 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.
- ACRONYMHERTAX, BOOG 2002-02
- hypothesisAlthough 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.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria1. Histologically documented invasive adenocarcinoma of the breast;
2. Women with previously chemotherapeutically untreated metastatic breast cancer with HER2neu overexpression (defined as 3+ IHC by DAKO HercepTest);
3. Patients having previously received adjuvant treatment with an anthracycline/ anthraquinone (maximum cumulative dose:
doxorubicin 360 mg/m2, epirubicin 750 mg/m2 or equivalent dose of other anthracycline/anthraquinone);
4. Patients over the age of 18;
ECOG performance status < = 2 and life expectancy >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;
7. Hemoglobin > 6 mmol / l and no blood transfusion within the previous 2 weeks;
8. WBC count > 3.0 x 109 cells/l and neutrophils >1.5 x 109 cells/l;
9. Platelets count > 100 x 109 cells/l;
10. No evidence of myelodysplastic syndrome or abnormal bone marrow reserve;
11. Creatinine < 1.5 upper normal limit (UNL) or creatinine clearance > 60 ml / min;
12. Total bilirubin < 1 x UNL;
13. ASAT (SGOT) and/or ALAT (SGPT) <2.5 x UNL;
14. Alkaline phosphatase < 5 x UNL;
15. ASAT and/or ALAT< 1.5 x UNL in combination with elevated alkaline phosphatase < 2.5 x UNL;
16. Previous radiotherapy is allowed if : End of radiotherapy more than 14 days prior to study entry, in case RT was given on relevant areas;
17. Patient has fully recovered from all acute toxic effects;
18. Normal Cardiac Function with LVEF by ECHO or MUGA > 50% or within UNL of the institution;
19. Written informed consent and accessible for treatment and follow up.
- Exclusion criteria1. 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 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 condition:
Cardiac insufficiency (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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2003
- planned closingdate31-dec-2005
- Target number of participants100
- InterventionsArm A: Comb. of trastuzumab + docetaxel;
Arm B: Trastuzumab followed by docetaxel.


Trastuzumab:
Loading dose of 4 mg/kg 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.
- Primary outcomeProgression free survival of total sequential versus combined treatment.
- Secondary outcomeResponse Rate and Overall Survival.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.G.M. Klijn
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.G.M. Klijn
- Sponsor/Initiator Breast Cancer Study Group (BOOG)
- Funding
(Source(s) of Monetary or Material Support)
Sanofi-Aventis, Roche Nederland BV
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD9-sep-2005 - 9-okt-2008


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