Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

NCT ID: NCT00403988

Last Updated: 2008-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2007-12-31

Brief Summary

Study Objective :

To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with or without Trastuzumab as a salvage regimen in patients with Metastatic Breast Cancer

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Oxaliplatin

Intervention Type: DRUG

vinorelbine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Metastatic, histologically or cytologically proven breast cancer.
• At least one bi-dimensionally measurable lesion.
• Previous treatment with chemotherapy as first line for metastatic disease is mandatory especially with anthracyclines +/- the Taxanes.
• Treatment as adjuvant is allowed.
• World Health Organization-ECOG performance status 0-2.
• Adequate renal function (Creatinine <= 1.4 or Creatinine clearance >= 30 ml/min)
• Adequate hepatic function (Liver Function Tests not more than 3 times the normal values)
• Adequate bone marrow reserve is required (Neutrophils (PMN) >= 2000/mm2 and Platelets >= 100,000/mm2)
• Patient who will receive Herceptin should have an over-expression of HER2-neu.

Exclusion Criteria

• Symptomatic peripheral neuropathy (National Cancer Institute common toxicity criteria grade more than one).
• Pregnant or breast-feeding.
• History of prior malignancies (with the exception of excised cervical carcinoma-in-situ or non-melanoma cell skin carcinoma).
• Receiving or had received, any treatment with experimental drugs.
• Had known brain or leptomeningeal involvement.
• Had a serious medical condition like congestive heart failure or an Ejection Fraction ≥ 40 %.
• The presence of bone as a sole site of metastasis.
• Radiation therapy to all areas of measurable disease less than four weeks before treatment.
• Creatinine two times above the normal range
• Hypercalcemia
• Evaluable but not a measurable disease as a sole site of metastasis: pleural effusion - Ascites - Pericardial effusion.
• Concomitant steroid intake for > 4 weeks
• Bilirubin two times above the normal range

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Locations

AmericanUBMC

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

L_9116

Identifier Type: -

Identifier Source: org_study_id