NCT06383767 A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
| NCT ID | NCT06383767 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 378 participants in total. It began in 2024-07-11 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Fei Ma, PhD
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06383767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06383767 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 378 participants.
Is NCT06383767 currently recruiting?
Yes, NCT06383767 is actively recruiting participants. Contact the research team at yong3.yuan@qilu-pharma.com for enrollment information.
Where is the NCT06383767 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06383767 clinical trial?
NCT06383767 is sponsored by Qilu Pharmaceutical Co., Ltd.. The principal investigator is Fei Ma, PhD at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 378 participants.
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