A Phase 2 interventional study of Gemcitabine combined with eribulin in HER2-negative Breast Cancer, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Status unknown. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Phase 2, Interventional, and Treatment
This study intends to conduct a single-arm, open-label Phase II multicenter clinical study of gemcitabine combined with eribulin regimen in the treatment of second-line above recurrent HER2-negative breast cancer. Patients with recurrent HER2-negative breast cancer were recruited, and the efficacy and clinical significance of gemcitabine combined with eribulin regimen in the treatment of recurrent HER2-negative breast cancer second-line above was studied.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 58 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 57 studies on the registry; 20 are open to participants now.
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Inclusion criteria
Exclusion criteria (Subjects can not enter the study if they meet any of the following conditions)
* 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
* 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.
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 Years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Fifth Affiliated Hospital, Sun Yat-Sen University