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

NCT06383767 | Recruiting Phase 3

• 1 other identifier: ESG401-301
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by IRC per RECIST 1.1

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

  Up to 24 months

Secondary Outcomes (10)

• Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

• Objective Response Rate (ORR)

  Up to 24 months

• Clinical Benefit Rate (CBR)

  Up to 24 months

• Duration of Response (DoR)

  Up to 24 months

Study Arms (2)

ESG401 for injection

EXPERIMENTAL

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

Drug: ESG401

Treatment of Physician's Choice

ACTIVE COMPARATOR

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

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

Interventions

ESG401 DRUG

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

ESG401 for injection

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

Eribulin, capecitabine, gemcitabine or vinorelbine

Treatment of Physician's Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals able to understand and give written informed consent.
• Males or females aged ≥ 18 years ;
• Histologically and/or cytologically confirmed HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy in metastatic settings;
• Patients who are eligible for a chemotherapy regimen in the control group;
• Patients with at least one measurable lesion per RECIST 1.1 criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
• Expected survival ≥ 12 weeks;
• Patients with adequate organ and bone marrow function;
• Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 180 days after the last dose.

You may not qualify if:

• Received chemotherapy, targeted therapy, immunotherapy, interventional therapy or other systemic anti-cancer therapie within 4 weeks before the first investigational product administration;
• Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
• Received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
• Prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy, or prior TROP2 targeted therapy, or use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration;
• New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months;
• Uncontrolled systemic bacterial, viral or fungal infections;
• Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases;
• Patients with Primary CNS malignancy；or patients with other malignancies within 3 years prior to the first dose;
• Patients with uncontrollable systemic diseases;
• Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea;
• Subjects with clinically significant cardiovascular disease;
• Human Immunodeficiency Virus (HIV) infection;
• Active hepatitis B or hepatitis C;
• Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient;
• Pregnant or lactating women.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Capecitabine; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Fei Ma, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yuan, Master Degree

CONTACT

+86 13820384005; yong3.yuan@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)