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

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT06383767
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 11, 2024
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
378 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ESG401 for injection
    IV infusion on day 1, 8 and15 of each 28 day cycle
  • Active Comparator: Treatment of Physician's Choice
    Eribulin 1.4 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle Capecitabine 1000 or 1250 mg/m2, po, from day 1 to 14 of each 21 day cycle Vinorelbine 25 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle Gemcitabine 1000 mg/m2, IV infusion on day 1,8 and 15 of each 28day cycle

Primary Outcome Measure

Progression-free survival (PFS) assessed by IRC per RECIST 1.1 [ Time Frame: Up to 24 months ]

Central Contacts

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