Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic 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 evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.

Eligibility criteria

Qualifiers

Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).

ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.

Life expectancy ≥ 3 months.

Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies.

Disqualifiers

Inflammatory breast cancer.

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

History of other malignancies prior to the start of study treatment.

Patients with known metastases to central nervous system.

Trial design

Treatments tested in this trial

  • SPH4336 Tablets
  • SPH4336 Tablets Placebo

Treatment groups

254 Participants
are divided into 2 treatment groups