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

Source: https://onco.cc/trials/nct06383767/  
OnCo record `nct06383767` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing ESG401 in HR-positive / HER2-negative breast cancer, now recruiting.

## Summary

A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06383767, led by Qilu Pharmaceutical, and recruiting on the registry. Official title: A Open-label, Randomised, 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. Planned enrolment is 378 participants (estimated). The study started in 2024-07-11 and primary completion is expected in 2027-06-30. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT06383767
- Phase: 3
- Setting: 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
- Sponsor: Qilu Pharmaceutical
- Enrolled: 378

## Sources

- ClinicalTrials.gov NCT06383767: https://clinicaltrials.gov/study/NCT06383767

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [ESG401](https://onco.cc/drugs/esg401/)
- companies: [Qilu Pharmaceutical](https://onco.cc/companies/qilu-pharmaceutical/)

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