None listed
Conditions
Brief summary
Approximately 20-30% of women with advanced breast cancer have a genetic alteration in the HER2 gene (human epidermal growth factor receptor-2), causing an over-expression of the HER2 protein in the tumour, which is associated with a more aggressive disease and a worse prognosis. Patients with this type of breast cancer benefit from treatment with Herceptin when the patient has not previously received chemotherapy for their advanced disease. This randomised clinical trial evaluates the use of Herceptin in combination with currently available chemotherapy treatments in providing a better outcome for these patients by delaying progression of the cancer and death with as little toxicity as possible. The trial will compare two treatments: (1) a combination of the drugs Taxotereâ, platinum salt and Herceptinâ and (2) a standard treatment of Taxotereâ and Herceptinâ in combination without platinum salt.
Interventions
Arm A: Docetaxel 100mg/m2 i.v, and Herceptin 4mg/kg i.v, on day 1 cycle 1 , then Herceptin 2mg/kg i.v, weekly until completion of chemotherapy. Chemotherapy will consist of 8, 21 day cycles. Hereceptin treatment will continue at 6mg/kg i.v, every 3 weeks until disease progression.
Sponsors
Roche pharmaceuticals
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Histologically or cytologically proven breast adenocarcinoma at first diagnosis.3. Metastatic breast cancer.4. Patients must have either measurable or nonmeasurable lesions according to the RECIST criteria.5. Primary tumour or metastatic tumour must show HER2 gene amplification by Fluorescence In-Situ Hybridization (FISH analysis) 6. Age >18 years and age <75 years. The upper age limit is not meant to be exclusionary but rather is based on the lack of safety data for the TCH regimen in women >75 years of age.7. Karnofsky Performance status index > or equal to 60%.8. Previous Therapya. Hormonal therapy- patients may have had previous hormonal therapy provided that the patient has stop the hormonal agent at the time of randomization.b. Chemotherapy- patients may have had adjuvant and/or neoadjuvant chemotherapy.c. Herceptin® - Patients having received a Herceptin®-containing regimen (except Herceptin® and taxane combination) as prior adjuvant and/or neoadjuvant therapy are eligible providing the relapse occurred at least 6 months following discontinuation of Herceptin®. Patients CANNOT have had Herceptin® for locally advanced or metastatic breast cancer.d. Radiotherapy -Previous radiation therapy may have been given providing at least 4 weeks has elapsed from the end of radiotherapy and study registration 9. Patients must have fully recovered from toxic effects of previous antitumor therapy, excluding alopecia.10. Normal cardiac function must be confirmed by LVEF (MUGA scan or echocardiography) and ECG within 1-month prior to registration. Result for the LVEF must be above or equal to the lower limit of normal for the institution.11. Normal Laboratory results: (within 7 days prior to registration)12. Complete radiology and tumour measurement work up within 4 weeks prior to registration.13. Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.14. Patients must be accessible for treatment and follow-up. Patients registered in this trial must be treated and followed in a participating centre.
Exclusion criteria
1. Prior chemotherapy for locally advanced (stage IIIB) disease, local recurrence or metastatic disease.2. Pregnant or lactating patients.3. Prior treatment with Herceptin® for advanced breast cancer.4. Prior Platinum salt containing regimen as adjuvant and/or neoadjuvant therapy for any past or current neoplasm.5. One lytic bone metastasis, blastic bone metastases, mixed bone metastases, lymphangitic carcinomatosis, ascites,pleural/pericardial effusion, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses that are notconfirmed and followed by imaging techniques, cystic lesions and/or irradiated not progressive lesions as onlymanifestation of metastatic disease.6. Prior history or known clinical manifestation of brain or leptomeningeal involvement.7. Non-metastatic disease as evidenced by local recurrent lesion within partially resected breast.8. Concurrent treatment with any other anti-cancer therapy.9. Pre-existing neuropathy-motor or sensory of a severity > or equal to grade 2 by NCI CTC criteria, version 2.0.10. Other serious illness or medical condition:11. Past or current history of neoplasm other than breast carcinoma, except for:a. Curatively treated non-melanoma skin cancer;b. Carcinoma in situ of the cervix;c. Other cancer curatively treated and with no evidence of disease for at least 10 years.12. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose13. Concomitant therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), given for breast cancer prevention or for osteoporosis. Patients must have discontinued theseagents prior to registration.14. Concomitant treatment with bisphosphonates may be used in patients with tumor lesions other than only bone lesions orfor non-oncologic indications.15. Definite contraindications for the use of corticosteroids.16. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational notmarketed drug within 30 days prior to study entry.17. Known allergy reactions to any of the drugs used in the study.18. Male patients
Outcome results
None listed