RecruitingPhase 2

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

China52 participantsStarted 2023-09-19

Plain-language summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. At least one measurable lesion .
✓. Laboratory test results meet the relevant requirements for organ function.
✓. Subjects who agree to take effective contraceptive measures.

✕. Inflammatory breast cancer.
✕. Patients unsuitable for endocrine therapy at the investigator's discretion.
✕. Have a History of other malignancies prior to the start of study treatment.
✕. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
✕. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
✕. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
✕. Pregnant or lactating women.
✕. 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; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.

Intracranial Objective response rate（iORR）

Timeframe: Approximately 3 years

NCT IDNCT05872347

SponsorShanghai Pharmaceuticals Holding Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Shusen Wang

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. At least one measurable lesion .
✓. Laboratory test results meet the relevant requirements for organ function.
✓. Subjects who agree to take effective contraceptive measures.

✕. Inflammatory breast cancer.
✕. Patients unsuitable for endocrine therapy at the investigator's discretion.
✕. Have a History of other malignancies prior to the start of study treatment.
✕. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
✕. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
✕. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
✕. Pregnant or lactating women.
✕. 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; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.