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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT05346861
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥18 and ≤75 years;
2. Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;
3. History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;
4. History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;
5. Previously reveived ≤2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included);
6. ECOG performance status of 0 to 1;
7. According to RECIST 1.1, at least one extracranial measurable lesion exists；
8. Signed informed consent.
Exclusion Criteria:
1. Patients with leptomeningeal metastasis or unstable brain metastasis;
2. History of neurological or psychiatric disorders;
3. Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
4. Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.
5. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
6. History of allergies to the drug components of this regimen;
7. History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;
8. Any other situations judged by investigator as not suitable for participating in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05346861
Study Brief:
Protocol Section:
NCT05346861