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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT07132502
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed HER-2 positive breast cancer (immunohistochemistry 3+ or 2+ with FISH positivity).Diagnosis of advanced breast cancer in accordance with AJCC staging criteria.
* Achieved complete response (CR) as evaluated by PET-CT or contrast-enhanced CT after receiving salvage therapy (within second-line) and maintained for 3 months.
* Negative ctDNA-MRD (circulating tumor DNA - minimal residual disease) detection.
* Negative CA153 detection.
* ECOG performance status score of 0-2.
* Expected survival ≥ 6 months.
* The patient has signed an informed consent form, willing to cooperate with the study and accept regular follow-up.
Exclusion Criteria:
* Concomitant other malignant tumors (excluding breast cancer).
* History of mental disorders or cognitive dysfunction, unable to cooperate with the study.
* Pregnant or lactating women.
* Severe cardiac, hepatic, or renal insufficiency.
* Currently participating in other clinical trials that may affect the evaluation of this study's results.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07132502
Study Brief:
Protocol Section:
NCT07132502