Status:
UNKNOWN
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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 toxici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00431704
Start Date
October 1 2007
End Date
December 1 2023
Last Update
March 24 2023
Active Locations (1)
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1
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131