Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Vinorelbine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

IV infusion on day 1, 8 and15 of each 28 day cycle

Eribulin 1.4 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Capecitabine 1000 or 1250 mg/m2, po, from day 1 to 14 of each 21 day cycle

Vinorelbine 25 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Gemcitabine 1000 mg/m2, IV infusion on day 1,8 and 15 of each 28day cycle

IV infusion on day 1,8, and 15 of each 28 day cycle

ESG401

Eribulin, capecitabine, gemcitabine or vinorelbine

Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)

Xiaoyan Xing, PhD

Fei Ma, PhD

The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.

This is a open-label, randomized, multicenter Phase 3 study to evaluate ESG401 versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.

A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer

A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

PFS was defined as the time from randomization to PD or death, whichever occurs first.

OS was defined as the time from randomization to death.

ORR was defined as the proportion of of patients with a CR and PR assessed by IRC and investigators per RECIST v 1.1

CBR was defined as the proportion of patients with a CR or PR or with SD at Week 24 assessed by IRC and investigators per RECIST v 1.1

From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first.

To assess the impact of ESG401 on disease related symptoms and quality of life of patients using the NCC-BC-A scale

Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings

Mean population clearance will be derived from pooled data of drug concentrations. Covariates of influence on drug clearance will be incorporated within a population pharmacokinetic model.

Mean population volume of distribution will be derived from pooled data of drug concentrations. Covariates of influence on volume of distribution will be incorporated within a population pharmacokinetic model.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer	NCT06383767	Metastatic Brea...	ESG401 Eribulin, capec...	18 Years -	Shanghai Escugen Biotechnology Co., Ltd
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer	NCT06383767	Metastatic Brea...	ESG401 Eribulin, capec...	18 Years -	Shanghai Escugen Biotechnology Co., Ltd

Spots Global Cancer Trial Database for eribulin, capecitabine, gemcitabine or vinorelbine (treatment of physician's choice)