Breast Cancer
Conditions
Keywords
Cancer, Breast cancer, First line treatment, Docetaxel, Carboplatin, Herceptin, Vinorelbine
Brief summary
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
Detailed description
Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.
Interventions
DRUGDocetaxel
Docetaxel at the dose of 75mg/m\^2 IV on day 1 every 3 weeks for 6 consecutive cycles
DRUGCarboplatin
Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
DRUGHerceptin
Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
DRUGVinorelbine
Vinorelbine at the dose of 60mg/m\^2 per os,weekly
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Performance status (WHO) 0-2 * Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received * HER-2 overexpression 2+ or 3+ using IHC or FISH + * Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents) * No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered) * More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered * No prior first line chemotherapy for metastatic disease * Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease * Paraffin block from the primary tumor available in the research lab * Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl) * Adequate cardiac function (LVEF \> 50%) * Informed consent
Exclusion criteria
* Pregnant or nursing * Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome * Positive pregnancy test * Motor or sensory neuropathy \> grade 1 according to NCIC Τoxicity Criteria * Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation * History of allergic reaction attributed to docetaxel * Psychiatric illness or social situation that would preclude study compliance * Other concurrent uncontrolled illness. * Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression between the two treatment arms | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
| Toxicity profile | During the time of chemotherpy |
Countries
Greece
Outcome results
None listed