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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT05891561
Eligibility Criteria:
Inclusion Criteria:
* Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease
* HER2-positive, ie. immunohistochemistry \[IHC\] 3+ or IHC 2+ and fluorescence in situ hybridisation \[FISH\]-positive according to ASCO/CAP 2018 guidelines
* complete clinical pathological information
* Eastern Cooperative oncology Group \[ECOG\] 0-1
* Currently not pregnant or breast-feeding
* Fine organ function
* Have good compliance with planned treatment, understand the study process and sign a written informed consent
Exclusion Criteria:
* Bilateral or metastatic breast cancer
* Receiving neoadjuvant treatment
* Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
* Severe systemic infections or other serious illnesses
* HIV infection, active hepatitis B or C infection
* Known allergy to or intolerance to a therapeutic drug or its excipients
* Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason
* Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment
* Receiving live vaccine within 30 days prior to initial administration of the investigational treatment
* History of mental illness or drug abuse that may affect compliance with the trial requirements
* The researchers determine that the patients were not suitable for the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05891561
Study Brief:
Protocol Section:
NCT05891561