Gemcitabine Combined With Eribulin Regimen in the Treatme... | NCT05263882

NCT05263882

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single arm	Other	Eribulin mesylate injection, specification: 2ml: 1mg/piece. Usage and dosage: 1.4mg/m2, intravenous bolus injection within 2-5 minutes, 21 days as a cycle, once on the 1st and 8th day of each cycle. Gemcitabine hydrochloride for injection, specification: 200mg: 1g/piece. Usage and dosage: administer gemcitabine (1000 mg/m2) intravenously over 30 minutes on the 1st and 8th day of every 21 days treatment cycle. The above combination regimen takes 21 days as a treatment cycle, and the efficacy is evaluated every 2 treatment cycles. The drug is continued until the disease progresses or intolerable adverse reactions occur.	Drug: Gemcitabine combined with eribulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine combined with eribulin	Drug	Eribulin mesylate injection, specification: 2ml: 1mg/piece. Usage and dosage: 1.4mg/m2, intravenous bolus injection within 2-5 minutes, 21 days as a cycle, once on the 1st and 8th day of each cycle. Gemcitabine hydrochloride for injection, specification: 200mg: 1g/piece. Usage and dosage: administer gemcitabine (1000 mg/m2) intravenously over 30 minutes on the 1st and 8th day of every 21 days treatment cycle. The above combination regimen takes 21 days as a treatment cycle, and the efficacy is evaluated every 2 treatment cycles. The drug is continued until the disease progresses or intolerable adverse reactions occur.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recent objective efficacy evaluation	In this clinical study, the efficacy evaluation method of RECIST version 1.1 was adopted, and the objective efficacy changes were evaluated according to the changes in the sum of the longest diameters of each target lesion.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Disease progression-free survival	progression-free survival is defined as the time from the date of randomization to any objectively documented tumor progression or patient death. In the event of a patient lost to follow-up, unexplained death or other anti-tumor therapy, the Disease progression-free survival was calculated up to this point.	2 years

Other Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	From the time the patient signed the informed consent form and was enrolled in the trial, any adverse medical event that occurred within 1 month after the end of treatment, regardless of whether it was causally related to the trial drug, was judged as an adverse event (AE). AEs were recorded truthfully during the trial, including the occurrence time, severity, duration, measures taken and outcomes of AEs. The investigator should follow up all AEs until symptoms disappear or the condition stabilizes. For SAEs, they should be followed until properly resolved even after the study ends.

Eligibility Module

Eligibility Criteria

Inclusion criteria

Histologically diagnosed histological examination confirmed breast cancer patients with locally advanced or metastatic HER2-negative (expression lack of human epidermal growth factor 2 (HER2) confirmed by central laboratory examination) and unsuitable for surgical treatment;
Received first-line or above systemic therapy in the past, with disease progression after the last treatment, and have used anthracyclines and/or taxanes, and currently there is no standard treatment regimen;
Must have at least one evaluable lesion according to RRECIST version 1.1 criteria (the longest diameter on spiral CT is at least 10mm, and the longest diameter on ordinary CT is at least 20mm);
Female, 18 years old ≤ aged ≤75 years old;
ECOG PS 0~2 points;
Expected survival period ≥ 3 months;
Sufficient blood function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥ 80×109/L and hemoglobin ≥ 8g/dL;
Sufficient liver function: total bilirubin ≤ 1.5 times the upper limit of normal (ULN); AST and ALT ≤ 2.5 times the upper limit of normal (ULN); alkaline phosphatase ≤ 5 times the upper limit of normal (ULN);
Sufficient renal function: serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min;
The electrocardiogram is basically normal;
Women with an intact uterus must have a negative pregnancy test result within 28 days prior to enrollment in the study (unless it has been 24 months of amenorrhea). If the pregnancy test is more than 7 days from the first dose, a urine pregnancy test is required for verification (within 7 days before the first dose);
Have not received radiotherapy, chemotherapy, targeted therapy and other treatments within 4 weeks before enrollment;
Signed the informed consent.

Exclusion criteria (Subjects can not enter the study if they meet any of the following conditions)

Pregnant, lactating women, or female patients who are fertile but not taking contraceptive measures;
Existing severe acute infection that has not been controlled; or purulent and chronic infection with persistent wound healing;
Patients with original serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease and resistant hypertension;
Those with bleeding tendency;
Individual with mental disorders/individual who cannot obtain informed consent;
Patients who use drugs and alcohol for a long time, which affects the evaluation of the test results;
Other conditions in which the investigator believes that the patient should not participate in this trial.