Locally Advanced or Metastatic Breast Cancer
Conditions
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.
Interventions
DRUGSPH4336 Tablets
SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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. History of other malignancies prior to the start of study treatment. 4. Patients with known metastases to central nervous system. 5. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF. 6. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery. 7. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment. 8. Pregnant or lactating women. 9. 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. 10. History of ischemic stroke or severe thromboembolic disease before the start of study treatment. 11. 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. 12. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product. 13. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment. 14. Presence of uncontrolled infections before the start of study treatment. 15. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders. 16. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 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 |
| Overall Survival (OS) | Approximately 8years | Determination of the overall survival times of all patients |
| 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 |
| Cmax | Approximately 3years | PK (Pharmacokinetics) parameters |
Countries
China
Contacts
Primary ContactShusen Wang
Outcome results
None listed