Gemcitabine Combined With Eribulin Regimen in the Treatment of Second-line Above Recurrent HER2-negative Breast Cancer

Phase 2

Not yet recruiting

• Conditions: HER2-negative Breast Cancer
• Interventions: Drug: Gemcitabine combined with eribulin

• Registration Number: NCT05263882
• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-16
• Status Verified: 2022-03
• Study Start: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-03
• Last Update Posted: 2022-03-03
• Primary Completion: 2023-12
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	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.

Primary Outcome Measures

Name	Time	Method
Recent objective efficacy evaluation	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Disease progression-free survival	2 years	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.