Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Triple Negative Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Vinorelbine

Taxane

Tubulin Modulators

Antimitotic Agents

The eribulin mesylate dose will be 1.4 mg/m2 administered as an intravenous bolus over 2 to 5 minutes on Days 1 and 8 of each 21-day cycle.

The vinorelbine dose will be 25 mg/m2 administered as an intravenous bolus on Days 1, 8, and 15 of each 21-day treatment cycle.

E7389 (Eribulin Mesylate)

Vinorelbine injection

This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Eligible female subjects will have measurable disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for assessment of disease.

Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

Eisai Co., Ltd.

anlotinib 12mg orally ,2 weeks on/1 week off ,Q3W; vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.

anlotinib and vinorelbine

vinorelbine 25-30mg/m2 intravenously ,D1/8,21 days as a cycle.Imaging will be performed after the twice anlotinib administration as 2 cycles.

Min Yan

Huimin Lv

Min Yan, Professor

The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with vinorelbine in the treatment of HER2- advanced breast cancer.

The eligible patients were HER2 negative advanced breast cancer patients who experienced failure of previous treatments with anthracyclines and/or taxanes , or hormone receptor-positive HER2-negative advanced breast cancer patients who progressed after at least first-line endocrine therapy in the advanced stage.The enrolled patients would receive anlotinib 12mg orally (2 weeks on/1 week off ,Q3W) plus vinorelbine 25-30mg/m2 intravenously (D1/8,21 days as a cycle) or vinorelbine 25-30mg/m2 intravenously (D1/8,21 days as a cycle).Imaging will be performed after the twice anlotinib administration as 2 cycles.This study is a randomized controlled, phase II clinical trial, and the treatment continued until radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.

Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer

A Controlled, Phase II Study of Anlotinib vs Placebo Combination With Vinorelbine for the Treatment of HER2- Advanced Breast Cancer

Individual participant data that underlie the results reported in this article, after de-identificationare available following article publication.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes	NCT02225470	HER2-Negative B... Triple Negative... Breast Cancer Cancer of Breas... Breast Tumors	E7389 (Eribulin... Vinorelbine inj...	18 Years - 70 Years	Eisai Inc.
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes	NCT02225470	HER2-Negative B... Triple Negative... Breast Cancer Cancer of Breas... Breast Tumors	E7389 (Eribulin... Vinorelbine inj...	18 Years - 70 Years	Eisai Inc.
Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer	NCT05296577	Breast Cancer	anlotinib and v... Vinorelbine inj...	18 Years -	Henan Cancer Hospital

Spots Global Cancer Trial Database for vinorelbine injection