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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT05113251
Eligibility Criteria:
Key Inclusion Criteria:
* Patients must be at least 18 years of age.
* Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition
* ECOG performance status of 0 or 1 at randomization
* Adequate organ and bone marrow function
* LVEF ≥ 50% within 28 days before randomization
* FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician
Exclusion Criteria:
* prior history of invasive breast cancer
* stage IV breast cancer (determined by AJCC staging system)
* any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) Note: This includes a second current breast primary malignancy (ie, bilateral breast cancer)
* history of DCIS (except those treated with mastectomy \>5 years prior to current diagnosis)
* History of, or current, ILD/pneumonitis
* Prior systemic therapy for the treatment of breast cancer
* Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05113251
Study Brief:
Protocol Section:
NCT05113251