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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06115902
Eligibility Criteria:
Inclusion Criteria:
* Subjects voluntarily participate in this study and sign informed consent;
* Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
* Breast cancer patients diagnosed with HER2 expression by pathological examination, with evidence of local focal recurrence or distant metastasis, are not suitable for surgery or radiotherapy for cure;
* Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials;
* At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
* The main organs function are normally;
* Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.
Exclusion Criteria:
* Concomitant disease and medical history:
1. Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
2. Adverse effects due to any prior treatment have not been restored according to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
3. Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
4. Long-term unhealed wounds or fractures;
5. Patients who have a prior history of interstitial lung disease/pneumonia requiring steroid intervention, or who are present with interstitial lung disease/pneumonia, or who are suspected of having interstitial lung disease/pneumonia on screening imaging and cannot be ruled out;
6. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;
7. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
8. Patients with any severe and/or uncontrolled disease;
* Tumor related symptoms and treatment:
1. Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug;
2. Received Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 week before the study treatment;
3. Patients whose imaging shows that the tumor has invaded important blood vessels or who are determined by the investigators to be highly likely to invade important blood vessels during follow-up studies and cause fatal major bleeding;
4. Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;
5. Known presence of cancerous meningitis or clinically active central nervous system metastasis; Patients who have been stable for at least 4 weeks after treatment and have been off corticosteroids for at least 2 weeks are excluded;
6. Patients with severe bone injury due to tumor bone metastasis;
* Study treatment related: people who are known to be allergic to the study drug or its excipients, or to humanized monoclonal antibody products;
* Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication;
* In the judgment of the investigator, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06115902
Study Brief:
Protocol Section:
NCT06115902