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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00903656
Eligibility Criteria:
Inclusion Criteria:
* Female patients, age ≥ 18 years
* Advanced or metastatic breast cancer, histologically confirmed
* Documented HER2 overexpression (IHC 3+ and/or FISH positive)
* At least one measurable lesion according to RECIST criteria. Patients with bone-only lesions are not eligible for study entry
* Documented disease progression
* Patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting
* Life expectancy of at least 12 weeks
* Performance status 0-1
* Cardiac ejection fraction \>= 50% as measured by echocardiogram or MUGA scan
* Adequate hematology, liver and renal function
Exclusion Criteria:
* Pregnant or lactating women
* Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
* Severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (CHF) or cardiac disease requiring a device)
* Ejection fraction below the institutional normal limit
* Maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin
* Active bacterial, viral or fungal infection
* Patients with clinically apparent brain metastases
* Positivity for HIV, Hepatitis B or C
* History of other malignancy; patients who have been disease-free for 5 years
* Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial
* Known hypersensitivity to the study drugs Lapatinib and Caelyx or their excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00903656
Study Brief:
Protocol Section:
NCT00903656