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 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT05375461
Eligibility Criteria:
Inclusion Criteria:
* 1 The subjects voluntarily joined the study and signed the informed consent, with good compliance.
* 2 Age: 18-75 years old (upon signing the informed consent);ECOG PS score: 0\~1; Expected survival ≥3 months.
* 3 participants with estrogen receptor-positive, HER2-Negative Advanced Breast Cancer were identified by pathological testing.
* 4 Patients at the relapse/metastatic stage were allowed to receive no more than 1 line of rescue chemotherapy or rescue endocrine therapy.
* 5 Confirmation of at least one measurable lesion according to RECIST1.1 criteria.
* 6 The main organs are functioning well and meet the following criteria: Routine blood examination criteria (no blood transfusion or hematopoietic stimulus drug correction within 7 days before screening) : a) hemoglobin (Hb) ≥100g/L; b) neutrophils absolute value (NEUT) ≥1.5×10\^9/L; c) Platelet count (PLT) ≥90×10\^9/L.
Biochemical tests should meet the following criteria: a) Total bilirubin (TBIL) ≤2.5 times the upper limit of normal (ULN); b) Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN.ALT and AST≤5×ULN with liver metastasis. c) Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate (CCR) ≥60ml/min.
The blood coagulation function test should meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international standardized ratio (INR) ≤1.5×ULN (no anticoagulant therapy); Cardiac ultrasound evaluation: left ventricular ejection fraction (LVEF)≥50%.
Exclusion Criteria:
* 1 Complicated diseases and medical history:
1. Has had other malignant tumors within 3 years or currently has other malignant tumors;
2. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
3. Unmitigated toxicity above CTCAE1 grade due to any prior treatment;
4. Severe infections (≥CTCAE2 grade) that were active or uncontrolled before the study treatment started;
5. Cirrhosis, active hepatitis；
6. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
* 2 Tumor-related symptoms and treatment:
1. Clinical evidence or history of central nervous system metastases (CNS) and/or cancerous meningitis or pneumomeningeal disease;
2. Had received chemotherapy within 3 weeks prior to the start of study treatment, and had received radiotherapy (except palliative radiotherapy for non-target lesions), hormone therapy, or other anti-tumor therapy within 2 weeks prior to the start of study treatment (washout period was calculated from the end of last treatment);
3. Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator).
* 3 Known to be allergic to fluvestone, TQB3616 or any excipient.
* 4 Participated in clinical trials of other antitumor drugs within 4 weeks prior to the initiation of study therapy.
* 5 Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05375461
Study Brief:
Protocol Section:
NCT05375461