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 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT04199520
Eligibility Criteria:
Inclusion Criteria:
* • Sign the informed consent
* ages 18-70, female;
* Breast cancer meets the following criteria:
* Histologically diagnosed invasive breast cancer, measure distant metastases with local standard assessment methods;
* Known hormone receptors and HER-2 status (ER, PR and HER2);
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤1;
* Estimated patient survival beyond 1 year;
* The time from diagnosis or systemic treatment to randomization does not exceed 1 year;
* According to RECIST 1.1, patients receiving chemotherapy or endocrine therapy are effective, including complete remission, partial remission, or stabilization. If the patient only receives endocrine therapy, the time is not less than 6 months; when receiving chemotherapy, the number of cycles is not less than 4 cycles;
* HER2-positive patients: the proportion of patients receiving targeted therapy is not less than 80% of the total HER2-positive patients;
* Patients had no obvious surgical contraindications before randomization;
* Researchers judge that they can comply with the research protocol
Exclusion Criteria:
* • Double breast cancer;
* Progression of metastases after systemic treatment;
* Poorly controlled brain metastases, liver metastases and multiple metastases;
* History of local breast radiotherapy after diagnosis;
* Have a history of other malignancies within 5 years prior to screening, with cervical cancer in situ treated properly except for non-melanoma skin cancer or stage I uterine cancer;
* Have undergone a major breast cancer-free surgical procedure within 4 weeks before randomization, or the patient has not fully recovered from such a surgical procedure;
* Have severe comorbidities or other comorbid conditions that interfere with planned treatment, or any other condition in which the investigator does not consider the patient suitable for participation in the study.
* Patients can withdraw informed consent at any time;
* pregnancy;
* The sponsor has determined that a major protocol violation that could compromise patient safety;
* Patients' non-compliance with protocol requirements on multiple occasions;
* The investigator believes that withdrawal from the trial will be of greatest benefit to the patient.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04199520
Study Brief:
Protocol Section:
NCT04199520