A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer

Sponsor
Tianjin Hemay Pharmaceutical Co., Ltd
Study ID
NCT06313983
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Hemay022+AI — DRUG
    hemay022：orally once daily，A 21-day cycle
  • Lapatinib+Capecitabine — DRUG
    Take the pills according to the instructions

Study Details

The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI. The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc.

Key Dates

Start date
Jan 8, 2022
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: Hemay022 and AI
    Hemay022 in combination with AI will be taken orally once daily. Planned dose of Hemay022 will be 500mg daily for 21 days.
  • Active Comparator: Lapatinib and Capecitabine
    lapatinib in combination with capecitabine will be taken in suitable dose until disease progression or death, etc.

Primary Outcome Measure

Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1 [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

Central Contacts

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