Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Carboplatin; Docetaxel; Trastuzumab; Vinblastine; Vinorelbine

Criteria

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