Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00431704
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00431704
Study Brief:
Protocol Section:
NCT00431704