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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT04683757
Eligibility Criteria:
Inclusion Criteria:
1. At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
2. ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
3. Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit
4. Patients who are willing to receive follow-up treatment in the research center.
Exclusion Criteria:
1. ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.
2. Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
3. Combined with other malignant tumors or had other malignant tumors in recent 5 years
4. Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state
5. Patients with life expectancy less than 3 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04683757
Study Brief:
Protocol Section:
NCT04683757