Recruiting NCT05860465
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
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, SPH4336 Tablets Placebo.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic Breast Cancer. 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/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy
Overview
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
- Drug SPH4336 Tablets
SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion - Drug SPH4336 Tablets Placebo
SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
Primary outcome measures
- Objective response rate [Time frame: Approximately 3years]
- Progression-free survival (PFS) [Time frame: Approximately 3years]
Secondary outcome measures (6)
- Cmax [Time frame: Approximately 3years]
- Tmax [Time frame: Approximately 3years]
- Disease control rate (DCR) [Time frame: Approximately 3years]
- Duration of remission (DOR) [Time frame: Approximately 3years]
- Overall Survival (OS) [Time frame: Approximately 8years]
- Safety and tolerability of the combination therapy since the start of any study treatment. [Time frame: Approximately 3years]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 22 centers
- 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
- Xiangyang Cancer Hospital — Wuhan
- Jiangsu Cancer Hospital — Nanjing
- … and 14 more centers
Identifiers
NCT: NCT05860465 · SPH4336-302