VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute, Naples
Sponsor:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00431704
First received: February 5, 2007
Last updated: February 28, 2013
Last verified: February 2013
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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 2013 (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: | February 28, 2013 |
| 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 May 16, 2013