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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Pharmaceuticals Holding Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

Prior treatment with any CDK4/6 (Cyclin dependent kinase)inhibitor.

Inflammatory breast cancer.

Patients unsuitable for endocrine therapy at the investigator's discretion.

History of other malignancies within 5 years prior to the start of study treatment.

Trial design

Treatments tested in this trial

  • SPH4336 Tablets 400mg
  • SPH4336 Tablets Placebo

Treatment groups

374 Participants
are divided into 2 treatment groups