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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT05206656
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old, voluntary consent and signed written informed consent
* ECOG 0\~2
* Pathologically diagnosed HER2-negative breast cancer patients with radiologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer; HR-positive patients were permitted
* At least one measurable disease lesion before treatment
* Never receive Eribulin Mesylate treatment or anti-angiogenetic therapies before recruitment
* Anticipated survival time is longer than three months
* Brain metastases with stable disease or without clinical symptom
* Blood routine test, liver and kidney function test meet the following criteria: PLT \> 100g / L, Hb \> 9g / L, Neutrophil \> 2.0 g/L; AST and ALT \< 2.5 upper limit of normal (ULN); Cr \< 1.0 ULN; TBIL \< 1.5ULN
* Previously treated with anthracycline-based and taxane-based chemotherapy regimens (at least one line of chemotherapy in the metastatic setting or the recurrence time is less than 1 year from the end of adjuvant or neoadjuvant chemotherapy); for HR-positive/HER2-negative patients, progressed after at least one line of endocrine therapy
* For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment; Men agreed to take appropriate contraceptive measures during the study treatment and at least half a year after the end of the treatment.
Exclusion Criteria:
* Pregnant or lactating women
* Active infection requiring systemic treatment
* HIV positive
* Suffering from or suspected of suffering from central neuromuscular system diseases
* Serious heart disease; uncontrollable hypertension; history of heavy hemorrheaï¼›recent operation within three months
* The investigator considered that the patient was not suitable for in this study, with any other situation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05206656
Study Brief:
Protocol Section:
NCT05206656