NCT00431704

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

Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.

Conditions

• Metastatic Breast Cancer

Interventions

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

Timeline

• Start date: 2007-10-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2007-02-06
• Last updated: 2023-03-24

Locations

1 site across 1 country: Italy