Breast cancer patients with metastases with HER2neu overexpression (3+ assessed by IHC DAKO HercepTest), previously untreated by chemotherapy, except for neoadjuvant or adjuvant (non-taxane containing) chemotherapy.
Conditions
Interventions
Arm 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 i
Sponsors
BOOG
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 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 60 ml / min; 12. Total bilirubin 50% or within UNL of the institution; 19. Written informed consent and accessible for treatment and follow up.
Exclusion criteria
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 <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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival of total sequential versus combined treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate and Overall Survival. | — |
Contacts
Public ContactJ.G.M. Klijn
Erasmus Medical Center, Daniel den Hoed Kliniek, Department of Medical Oncology, P.O. Box 5201
Outcome results
None listed