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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05806060
Eligibility Criteria:
Inclusion Criteria:
* ECOG Performance Status of 0-1
* Expected lifetime of not less than three months
* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) with BLIS subtype
* Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection
* Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
* At least one measurable or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy
* The functions of major organs are basically normal
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
* Have the cognitive ability to understand the protocol and be willing to participate and to be followed up
Exclusion Criteria:
* Symptomatic, untreated, or actively progressing CNS metastases
* Significant cardiovascular disease
* Adverse reactions of Grade ≥1 that are still continuing due to previous treatments. Exceptions are those of hair loss or which researchers take it as exception
* Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access)
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma
* Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the use and absorption of drugs
* Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites)
* Participated in clinical trials of other antitumor drugs within 4 weeks before first taking the investigational drug
* Long-term unhealing wound or incomplete healing of fracture
* Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic phase with abnormal liver function
* Allergic constitution, or known allergic history of the drug components of this trial; Or allergic to other monoclonal antibodies
* Patients with a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), were not allowed to enter the group; If there is occult blood in the stool (+), gastroscopy is required
* Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this trial
* Urine protein ≥2+ and 24h urine protein quantitative \> 1.0 g
* Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05806060
Study Brief:
Protocol Section:
NCT05806060