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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT04246502
Eligibility Criteria:
Inclusion Criteria:
* HER2 positive recurrent or metastasis breast cancer.
* Patients with measurable disease are eligible.
* Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
* Adequate organ function.
* Signed, written inform consent obtained prior to any study procedure.
Exclusion Criteria:
* History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
* History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
* Assessed by the investigator to be unable receive systemic chemotherapy.
* History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
* Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04246502
Study Brief:
Protocol Section:
NCT04246502