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

A

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

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

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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