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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT04936295
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent form;
2. 18-75 years old;
3. Women in any menstrual state, premenopausal or perimenopausal patients need to receive luteinizing hormone releasing hormone(LHRH) analogue;
4. Eastern Cooperative Oncology Group (ECOG) score \[0-1\] points;
5. The expected survival period is ≥12 weeks;
6. The diagnosis of invasive carcinoma by histology or cytology; Estrogen receptor (ER) positive (defined as \>1% nuclear ER staining); HER2 negative (defined as IHC 0 or 1+, or HER2(2+) with HER2 FISH detection no amplification);
7. Inoperable or recurrent/metastatic breast cancer patients with aromatase inhibitor treatment failure;
8. In the state of disease progression before enrollment;
9. There are FGFR mutations, which meets any of the following: ①Immunohistochemical method: any subtype of FGFR1/2/3/4 is positive; ② Gene detection results of tissue/blood sample shows that any subtype of FGFR1/2/3/4 has functional variation such as amplification, activating mutation or fusion;
10. Measurable disease according to RECIST version 1.1 or only bone metastasis;
11. Adequate hematological, hepatic function;
12. Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥50%.
Exclusion Criteria:
1. Have used Fulvestrant or its analogues;
2. History of other primary malignancy;
3. Allergic to the ingredients of Anlotinib Hydrochloride Capsules;
4. Previously received targeted drug therapy for FGFR;
5. Received chemotherapy within 4 weeks before enrollment;
6. Received endocrine therapy within 2 weeks before enrollment;
7. Patients with currently symptomatic brain or meningeal metastasis;
8. Concomitant diseases/conditions that is not controllable, and any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study;
9. Patients who cannot accept drugs orally;
10. Any other situation that the investigator judges cannot be enrolled in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04936295
Study Brief:
Protocol Section:
NCT04936295