Eligibility Module

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 @ 1:44 AM
Ignite Modification Date: 2025-12-25 @ 1:44 AM
NCT ID: NCT01160094
Eligibility Criteria: * Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice); * Older than 18 years old; * Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer; * Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment; * Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, OR receiving standard treatment with * Lapatinib-capecitabine at conventional doses, for no longer than 10 weeks from the start of the treatment to the date of inclusion in the study; * Signed consent to participate and release information for this study.
Healthy Volunteers: False
Sex: FEMALE
Minimum Age: 18 Years
Study: NCT01160094
Study Brief:
Protocol Section: NCT01160094