Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments vinorelbine, carboplatin, trastuzumab
Phase phase 2
Target HER2
Sponsor National Cancer Institute, Naples
Start date October 2007
End date July 2016
Trial size 39 participants
Trial identifier NCT00431704, 2006-003994-28, VinCaT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vinorelbine
25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
carboplatin
AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
trastuzumab
8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression

Primary Outcomes

Measure
objective response rate
time frame: after 3 and 6 cycles of therapy
toxicity
time frame: after every cycle of therapy

Secondary Outcomes

Measure
time to progression
time frame: at 12 months, end of study
overall survival
time frame: at 12 months, end of study

Eligibility Criteria

Female participants from 18 years up to 75 years old.

Inclusion Criteria: - Histological or cytological diagnosis of breast cancer - Stage IV disease - None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted) - Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+) - ECOG Performance Status 0-2 - Age >18 and < 75 years - Left Ventricular Ejection Fraction (LVEF) >50% - Life expectancy >3 months - Signed informed consent Exclusion Criteria: - Absence of measurable or evaluable disease - Life expectancy < 3 months - ECOG performance status > 2 - History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ). - Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease) - Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted) - Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl - Creatinine > 1.5 x the upper normal limits - GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases - GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases - Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia - Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study - Male gender - Pregnant or lactating women - Refusal or incapacity to provide informed consent - Inability to comply with follow up

Additional Information

Official title Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
Principal investigator Andrea De Matteis, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute, Naples.