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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT07012720
Eligibility Criteria:
Inclusion criteria:
1. Voluntary enrollment, able to understand and sign the informed consent form;
2. Female, aged 25 to 70;
3. Meet the indications for neoadjuvant therapy (based on the indicated population clearly defined in the 2023 CSCO Breast Cancer Diagnosis and Treatment Guidelines);
4. No previous systemic treatment for breast cancer;
5. The neoadjuvant treatment regimen met the inclusion requirements: triple-negative breast cancer (T-EC+antiPD-1/T-EC/antiPD-1) HER2+ HR-breast cancer (EC-THP/HP), HER2-HR+ breast cancer (AI/AI+CDK4/6i);
6. Tumor specimens can be obtained (including puncture, minimally invasive, incision biopsy, and surgery);
7. A complete pathological report can be obtained.
Exclusion Criteria:
1. The patient did not sign the informed consent form;
2. Tumor specimens cannot be obtained (including puncture, minimally invasive, incision biopsy, and surgery);
3. Patients with severe systemic infections or accompanied by other serious diseases;
4. Have received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any previous reason;
5. Does not meet the indications for neoadjuvant therapy;
6. Neoadjuvant treatment regimens are not included in the neoadjuvant treatment regimens defined in this study;
7. Other circumstances where the researcher deems it unsuitable for inclusion. Criteria for Subjects to withdraw from the study (1) All subjects can voluntarily withdraw at any stage of the study without being discriminated against or retaliated against, and their medical treatment will not be affected.
(2) Furthermore, the subjects may withdraw from this study under the following circumstances:
1. Withdrawal decided by the researcher:
A: The patient does not meet the indications for the above-mentioned designated neoadjuvant regimen; B: In cases where the subjects are not suitable to continue the trial during the research process, such as when the patients cannot tolerate immunotherapy or chemotherapy, the established neoadjuvant treatment plan needs to be terminated; C: Those who accept the neoadjuvant treatment regimen specified in this study and show disease progression in the cycle evaluation need to terminate the neoadjuvant treatment in advance and undergo surgical resection of the tumor tissue.
D: Adverse events occurred. It was judged by the researchers that continuing to participate in the study would have an adverse impact on the safety of the subjects.
E: Subjects with poor compliance, which affects the assessment of tolerance; F: The researcher requests the subjects to withdraw from the study for any medical reason; G: The researchers believe that the subjects have other circumstances that make them unsuitable to continue participating in the trial.
2. Voluntary withdrawal of the subjects:
A: The subject was unwilling to continue participating in the study and voluntarily withdrew the informed consent form.
B: Loss to follow-up (Before loss to follow-up, subjects who have completed three visits should be attempted to be contacted).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT07012720
Study Brief:
Protocol Section:
NCT07012720