Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer

Trial Details

NCT ID
NCT05744687
Phase
PHASE2 / PHASE3
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • SPH4336 Tablets 400mg
  • SPH4336 Tablets Placebo
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guiyang, Guizhou, China|26.58333,106.71667
  • Anyang, Henan, China|36.096,114.38278
  • Luoyang, Henan, China|34.67345,112.43684

Key Eligibility Criteria

  • Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
  • Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
  • ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1.
  • Life expectancy ≥ 3 months.

For full eligibility, visit ClinicalTrials.gov.

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