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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	Female

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF). 2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1. 3. Life expectancy ≥ 3 months. 4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies. 5. At least one measurable lesion . 6. Laboratory test results meet the relevant requirements for organ function. 7. Subjects who agree to take effective contraceptive measures.

Exclusion Criteria:

1. Inflammatory breast cancer. 2. Patients unsuitable for endocrine therapy at the investigator's discretion. 3. Have a History of other malignancies prior to the start of study treatment. 4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF. 5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery. 6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment. 7. Pregnant or lactating women. 8. 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%. 9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment. 10. 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. 11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product. 12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment. 13. Presence of uncontrolled infections before the start of study treatment. 14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders. 15. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05872347
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Pharmaceuticals Holding Co., Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer Brain Metastases

Arms & Interventions

Arms

Experimental: SPH4336 Tablets

SPH4336 Tablets; Letrozole tablets; Fulvestrant; Exemestane

Interventions

Drug: - SPH4336 Tablets

SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral.

Contact a Trial Team

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International Sites

Anhui provincial hospital, Hefei, Anhui, China

Status

Recruiting

Address

Anhui provincial hospital

Hefei, Anhui, 230002

Site Contact

Yueyin Pan

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