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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT07173556
Eligibility Criteria:
Inclusion Criteria:
* Voluntarily participate in the clinical trial, understand and sign the informed consent form, and agree to comply with the requirements specified in the protocol.
* Age ≥ 18 years.
* Female subjects must be postmenopausal and meet the trial requirements.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
* Life expectancy ≥ 3 months.
* Histologically or cytologically confirmed breast cancer.
* Based on the most recent biopsy results of primary or metastatic tumor tissue, immunohistochemistry (IHC) confirms ER-positive status and HER-2-negative status.
* At least one measurable target lesion according to RECIST v1.1.
* Adequate bone marrow function within 2 weeks (14 days) prior to the initiation of study treatment, without the need for transfusion or growth factor (G-CSF, EPO, TPO, etc.) support.
* Adequate liver function.
* Renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Ccr) \> 30 mL/min, with no significant electrolyte imbalances that are difficult to correct.
* Coagulation function: International Normalized Ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Exclusion Criteria:
* Presence of symptomatic visceral disease or any other condition deemed unsuitable for endocrine therapy as per the investigator's judgment.
* Presence of unresolved toxicities from prior therapy that have not recovered to ≤ CTCAE grade 1, excluding alopecia (any grade) or other toxicities considered by the investigator to pose no safety risk.
* Received anti-tumor drug therapy within the specified time window prior to the first dose of the investigational drug.
* Prior treatment with an experimental SERD or experimental ER antagonist.
* Received radiotherapy within 4 weeks prior to the first dose of the investigational drug.
* Used a strong CYP3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first dose.
* Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has not recovered from significant side effects, or has significant traumatic injury, non-healing wounds, or fractures.
* History of other active malignancies within 5 years prior to the first dose of the investigational drug.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Inability to swallow the formulation, or gastrointestinal impairment/disease that may affect adequate absorption of the investigational drug.
* Known clinically significant liver disease, including Child-Pugh class B or C, active viral hepatitis, or other hepatitis.
* Current documented grade 1 or higher pneumonitis or interstitial lung disease.
* Clinically significant pleural effusion, ascites, or pericardial effusion, defined as detectable on examination and requiring drainage within the past 2 weeks or additional medication to control symptoms.
* Clinically significant uncontrolled cardiac disease and/or recent cardiac events.
* History of bleeding tendency, thrombosis, or tumor embolism.
* Planned treatment with everolimus and presence of uncontrolled diabetes despite adequate therapy.
* Allergy to any of the investigational medicinal products or their components.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07173556
Study Brief:
Protocol Section:
NCT07173556