Using SPH4336 with hormone therapy for advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of SPH4336, a new treatment, in combination with endocrine therapy for patients with locally advanced or metastatic breast cancer that has progressed after treatment with CDK4/6 inhibitors. The trial includes both Phase 2 and Phase 3 components to assess the drug's effectiveness and safety profile. Participants must have measurable lesions and meet specific health criteria to be eligible for the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated Cancer Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Liuzhou people's Hospital
  Liuzhou, Guangxi, China Recruiting
• Anyang Cancer Hospital
  Anyang, He'nan, China Recruiting
• The First Affiliated Hospital of Henan University of Science and Technology
  Luoyang, He'nan, China Recruiting
• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Harbin Medical University cancer Hospital
  Harbin, Heilongjiang, China Recruiting

Study contacts

• Study coordinator: Shusen Wang
• Email: wangshs@sysucc.org.cn
• Phone: 0086-020-87343811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.