Recruiting NCT06383767
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ESG401, Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice).
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
Overview
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.
Detailed description
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.
Interventions
- Drug ESG401
IV infusion on day 1,8, and 15 of each 28 day cycle - Drug Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
Eribulin, capecitabine, gemcitabine or vinorelbine
Primary outcome measures
- Progression-free survival (PFS) assessed by IRC per RECIST 1.1 [Time frame: Up to 24 months]
Secondary outcome measures (10)
- Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1 [Time frame: Up to 24 months]
- Overall Survival (OS) [Time frame: Up to 24 months]
- Objective Response Rate (ORR) [Time frame: Up to 24 months]
- Clinical Benefit Rate (CBR) [Time frame: Up to 24 months]
- Duration of Response (DoR) [Time frame: Up to 24 months]
- Quality of life evaluated using the NCC-BC-A scale [Time frame: Up to 24 months]
- Adverse events(AEs) and severe adverse events (SAEs) [Time frame: From signing the ICF up to last dose plus 30 days]
- Clearance [Time frame: Up to 24 months]
- Volume of distribution [Time frame: Up to 24 months]
- ADA [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT06383767 · ESG401-301