Conditions: Breast Neoplasms Breast Cancer
Keywords: Breast Neoplasms Breast Cancer Vinflunine Vinca Alkaloid Javlor
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer

Detailed description:
If the tumor is HER2neu positive, eligible patients will receive trastuzumab and vinflunine intravenously (IV) every 3 weeks.

If the tumor is HER2neu negative, eligible patients will receive vinflunine intravenously (IV) every 3 weeks.

Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression. Evaluation of cancer will be every 9 weeks.

Arms:
arm 1: Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes, repeated every 21 days arm 2: Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2.

Interventions: intervention 1: Vinflunine intervention 2: Trastuzumab
Intervention descriptions: intervention 1: Novel second generation vinca alkaloid intervention 2: Anti-HER2 monoclonal antibody

Protocol document: