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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03945604
Eligibility Criteria:
Inclusion Criteria:
* Signed the informed consent.
* Female aged ≥18 years old.
* Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer.
* No more than 2-line chemotherapy failed at the stage of recurrence and metastasis .
* Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment
* At least one measuring lesion that confirmed by RECIST v1.1 standard.
* The patients can swallow pills.
* Have a life expectancy of at least 12 weeks.
* The functions of vital organs meet protocal requirements.
Exclusion Criteria:
* Subjects had any history of active autoimmune disease .
* Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors.
* Subjects have untreated central nervous system metastasis.
* History of hypertension and antihypertensive medications are not well controlled.
* Some clinical symptoms or diseases of the heart that are not well controlled.
* History of immunodeficiency including HIV-positive.
* Subjects had active infections.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03945604
Study Brief:
Protocol Section:
NCT03945604