Evaluating ESG401 for advanced breast cancer

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

This study is testing a new treatment called ESG401 to see if it can help people with advanced breast cancer who haven't had success with other chemotherapy options.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06383767 on ClinicalTrials.gov

What this trial studies

This Phase 3 study aims to assess the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have previously failed at least one line of systemic chemotherapy. It is an open-label, randomized, multicenter trial comparing ESG401 to the Treatment of Physician's Choice (TPC), which includes options like Eribulin, capecitabine, gemcitabine, or vinorelbine. The study will enroll participants who meet specific eligibility criteria, including having measurable lesions and adequate organ function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with HR+/HER2- breast cancer that is locally advanced or metastatic and who have failed at least one prior chemotherapy.

Not a fit: Patients who have received systemic anti-cancer therapy within 4 weeks prior to the study or those with other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced breast cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise in treating HR+/HER2- breast cancer with novel therapies, suggesting potential for success with this approach.

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.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Fei Ma, PhD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Yong Yuan, Master Degree

Conditions Metastatic Breast Cancer