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

NCT ID: NCT00453635

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2008-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel at the dose of 75mg/m\^2 IV on day 1 every 3 weeks for 6 consecutive cycles

Carboplatin

Intervention Type: DRUG

Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles

Herceptin

Intervention Type: DRUG

Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks

2

Vinorelbine + Herceptin (VHer)

Group Type: EXPERIMENTAL

Herceptin

Intervention Type: DRUG

Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks

Vinorelbine

Intervention Type: DRUG

Vinorelbine at the dose of 60mg/m\^2 per os,weekly

Interventions

Docetaxel

Docetaxel at the dose of 75mg/m\^2 IV on day 1 every 3 weeks for 6 consecutive cycles

Intervention Type: DRUG

Carboplatin

Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles

Intervention Type: DRUG

Herceptin

Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks

Intervention Type: DRUG

Vinorelbine

Vinorelbine at the dose of 60mg/m\^2 per os,weekly

Intervention Type: DRUG

Other Intervention Names

Taxotere; Navelbine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Hellenic Oncology Research Group

Principal Investigators

Dimitris Mavroudis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Dep of Medical Oncology

Locations

University Hospital of Crete

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, , Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, , Greece

401 Military Hospital of Athens

Athens, , Greece

Air Forces Military Hospital of Athens

Athens, , Greece

Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, , Greece

State General Hospital of Larissa

Athens, , Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, , Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/03.08

Identifier Type: -

Identifier Source: org_study_id