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

American University of Beirut Medical Center

Status and phase

Terminated

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: vinorelbine

Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00403988

L_9116

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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