Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
About this study
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.
- Condition
- Locally Advanced or Metastatic Breast Cancer
- Tested
- SPH4336 Tablets, SPH4336 Tablets Placebo
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Who can join
- Age
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 18 years
- Maximum age: 75 years
- Eligible sex: Female
- Study condition: Locally Advanced or Metastatic Breast Cancer
- 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 16
- 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.
- 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; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.
- 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 \> 104 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.
Where
22 sites, 22 recruiting
Anyang Cancer Hospital
Anyang, He'nan, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Jilin Cancer Hospital
Changchun, Jilin, China
Fujian Cancer Hospital
Fuzhou, China
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
and 16 more sites on ClinicalTrials.gov
Contact
-
Shusen Wang
0086-020-87343811 wangshs@sysucc.org.cn
Potential match only. Final eligibility is determined by the study team.