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OncoMatch/Clinical Trials/NCT05860465

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Is NCT05860465 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies SPH4336 Tablets for locally advanced or metastatic breast cancer.

Phase 2/3RecruitingShanghai Pharmaceuticals Holding Co., LtdNCT05860465Data as of May 2026

Treatment: SPH4336 TabletsThis 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

Laboratory test results meet the relevant requirements for organ function.

Kidney function

Laboratory test results meet the relevant requirements for organ function.

Liver function

Laboratory test results meet the relevant requirements for organ function.

Cardiac function

History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.

Laboratory test results meet the relevant requirements for organ function. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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