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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05945927
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment
* Had prior treatment for breast cancer which must contain a taxane and trastuzumab
* Get the treatment of T-DM1 for the first time after diagnosis of breast cancer
Exclusion Criteria:
* Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling
* Has been previously treated with T-DM1 before current clinical visit
* Currently participating in any clinical trials
* Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05945927
Study Brief:
Protocol Section:
NCT05945927