Evaluating ESG401 for advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yong3.yuan@qilu-pharma.com
• Phone: +86 13820384005

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.