VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT00431704
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • vinorelbine — DRUG
    25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
  • carboplatin — DRUG
    AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
  • trastuzumab — DRUG
    8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression

Study Details

The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.

Key Dates

Start date
Oct 31, 2007
Status verified
Mar 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: vinorelbine, carboplatin, trastuzumab

Primary Outcome Measure

objective response rate [ Time Frame: after 3 and 6 cycles of therapy ]

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