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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT00426556
Eligibility Criteria:
Inclusion Criteria:
* Female or male patients ≥ 18 years old with WHO performance status ≤ 1
* HER-2 over-expressing metastatic breast cancer cells confirmed by histology
* Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l)
* Patient resistance to trastuzumab and taxanes (Phase ll)
* Measurable disease according to RECIST (Phase ll)
* Patients neurologically stable with adequate bone marrow, liver and renal function
Exclusion Criteria:
* Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
* Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
* Patients who have previously received mTOR inhibitors
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00426556
Study Brief:
Protocol Section:
NCT00426556