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

Hellenic Oncology Research Group

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Herceptin; Drug: Docetaxel; Drug: Carboplatin; Drug: Vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT00453635

CT/03.08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

1

Experimental group

Description:

Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)

Treatment:

Drug: Carboplatin

Drug: Docetaxel

Drug: Herceptin

2

Experimental group

Description:

Vinorelbine + Herceptin (VHer)

Treatment:

Drug: Vinorelbine

Drug: Herceptin