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

This study is currently recruiting participants.
Verified January 2014 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00431704
First received: February 5, 2007
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: vinorelbine
Drug: carboplatin
Drug: trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • objective response rate [ Time Frame: after 3 and 6 cycles of therapy ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: after every cycle of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to progression [ Time Frame: at 12 months, end of study ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: at 12 months, end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: October 2007
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vinorelbine, carboplatin, trastuzumab 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431704

Contacts
Contact: Francesco Perrone, M.D., Ph.D +39 081 5903 ext 571 francesco.perrone@usc-intnapoli.net
Contact: Massimo Di Maio, M.D. +39 081 5903 ext 383 massimo.dimaio@usc-intnapoli.lnet

Locations
Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C Recruiting
Napoli, Italy, 80131
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Andrea De Matteis, M.D. NCI Naples, Division of Medical Oncology C
Principal Investigator: Francesco Perrone, M.D., Ph.D. NCI Naples, Clinical Trials Unit
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00431704     History of Changes
Other Study ID Numbers: VinCaT, 2006-003994-28
Study First Received: February 5, 2007
Last Updated: January 2, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
advanced
her-2 positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Vinblastine
Trastuzumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014