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 groupsSponsors and collaborators
Source ClinicalTrials.gov