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A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

Phase 2
18 Years
75 Years
Not Enrolling
Breast Neoplasms

Thank you

Trial Information

A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:

During the Study Conduct

Safety Issue:



Lebanon: Ministry of Public Health

Study ID:




Start Date:

June 2004

Completion Date:

December 2007

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma