Recruiting NCT05872347
Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPH4336 Tablets.
- Who it may be relevant to
- Registry conditions: Breast Cancer Brain Metastases. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.
Overview
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.
Interventions
- Drug SPH4336 Tablets
SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral.
Primary outcome measures
- Intracranial Objective response rate（iORR） [Time frame: Approximately 3 years]
Secondary outcome measures (10)
- Intracranial Duration of remission (iDOR) [Time frame: Approximately 3 years]
- Intracranial Disease control rate (iDCR) [Time frame: Approximately 3 years]
- Progression-free survival (PFS) [Time frame: Approximately 3 years]
- Overall Survival (OS) [Time frame: Approximately 8 years]
- Extracranial Objective response rate（eORR） [Time frame: Approximately 3 years]
- Extracranial Disease control rate (eDCR) [Time frame: Approximately 3 years]
- Extracranial Duration of remission (eDOR) [Time frame: Approximately 3 years]
- Cmax [Time frame: Approximately 3 years]
- Tmax [Time frame: Approximately 3 years]
- Safety and tolerability [Time frame: Approximately 3 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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%.
- History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
- Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA > 2,000 IU/mL or > 10(4) copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
- History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
- Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
- Presence of uncontrolled infections before the start of study treatment.
- Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
- Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 25 centers
- Anhui provincial hospital — Hefei
- The First Affiliated Hospital of Anhui Medical University — Hefei
- Affiliated Cancer Hospital, Sun Yat-sen University — Guangzhou
- Liuzhou people's Hospital — Liuzhou
- Anyang Cancer Hospital — Anyang
- The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
- The Fourth Hospital of Hebei Medical University — Shijiazhuang
- Harbin Medical University cancer Hospital — Harbin
- … and 17 more centers
Identifiers
NCT: NCT05872347 · SPH4336-202