Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
- Conditions
- Locally Advanced or Metastatic Breast Cancer
- Interventions
- Drug: SPH4336 TabletsDrug: SPH4336 Tablets Placebo
- Registration Number
- NCT05860465
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 254
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPH4336 Tablets SPH4336 Tablets SPH4336 Tablets; Letrozole tablets; Fulvestrant injection SPH4336 Tablets Placebo SPH4336 Tablets Placebo SPH4336 Tablets Placebo; Letrozole tablets; Fulvestrant injection
- Primary Outcome Measures
Name Time Method Objective response rate Approximately 3years tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Progression-free survival (PFS) Approximately 3years from the start date of study treatment to the date of progression disease or death , whichever occurred first.
- Secondary Outcome Measures
Name Time Method Tmax Approximately 3years PK (Pharmacokinetics) parameters
Cmax Approximately 3years PK (Pharmacokinetics) parameters
Disease control rate (DCR) Approximately 3years DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Safety and tolerability of the combination therapy since the start of any study treatment. Approximately 3years Adverse event type, incidence, duration, correlation with study drug
Duration of remission (DOR) Approximately 3years DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause
Overall Survival (OS) Approximately 8years Determination of the overall survival times of all patients
Trial Locations
- Locations (22)
Liuzhou people's Hospital
🇨🇳Liuzhou, Guangxi, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Xiangyang Cancer Hospital
🇨🇳Wuhan, Hubei, China
The second people's hospital of neijiang
🇨🇳Neijiang, Sichuan, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Shenzhen Hospital of University of Hong Kong
🇨🇳Shenzhen, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Affiliated Cancer Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Zhejiang cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China