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:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT00513058
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced breast cancer (metastatic or locally advanced)
* Tumor overexpressing HER2 (HER2 3+ by IHC OR HER2 2+ by IHC and FISH positive) in samples from the primary and/or secondary tumor
* Measurable or evaluable disease
* Cancer is progressive after treatment with at least 1 line or, at most, 2 lines, of chemotherapy that included trastuzumab (Herceptin®)
* Patients presenting with treated asymptomatic cerebral metastases or leptomeningeal metastases may be included if they are neurologically stable and have not received steroids or anticonvulsant treatment for at least 4 weeks before study entry
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Female
* Menopausal status not specified
* Patients must have an estimated survival of at least 3 months
* WHO performance status (ECOG) 0-2
* Hemoglobin ≥ 9 g/dL
* ANC ≥ 1,500/mm³
* Platelets ≥ 100,000/mm³
* Total bilirubin ≤ 2.5 mg/dL
* ALT and AST ≤ 3 times upper limit of normal
* Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min
* LVEF ≥ 50% (echographic or isotopic method)
* Potentially reproductive patients must agree to use an effective contraceptive method while on study treatment
* Patients must be affiliated with a Social Security system
Exclusion criteria:
* Uncontrolled cardiac pathology
* Dysphagia or inability to swallow the vinorelbine ditartrate soft capsules
* Malabsorption syndrome or disease significantly affecting gastrointestinal function
* Preexisting neuropathy (grade ≥ 2)
* Pregnant women, women who are likely to become pregnant, or women who are breastfeeding
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Individuals deprived of liberty
Exclusion criteria:
* Prior major resection of stomach or proximal bowel that could affect absorption of oral drugs
* Prior vinorelbine
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00513058
Study Brief:
Protocol Section:
NCT00513058