Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · May 14, 2023

Keywords

ClinConnect Summary

This clinical trial is examining a new treatment called SPH4336, which is being tested alongside standard endocrine therapy for women with breast cancer that has spread to the brain. The goal is to find out if this combination is safe and effective for patients who cannot undergo surgery or other local treatments. The trial is currently looking for female participants between the ages of 18 and 75 who have advanced breast cancer and can still perform daily activities with minimal assistance.

To join the study, participants need to understand the trial and agree to take part by signing a consent form. They should have at least one measurable tumor and a life expectancy of at least three months. However, some women may not be eligible, particularly those with certain types of breast cancer, previous serious heart issues, or certain infections. If you decide to participate, you can expect to be closely monitored by healthcare professionals throughout the trial to assess your health and the effects of the treatment. Your well-being is the top priority, and this study aims to explore new options that could help improve outcomes for patients with this challenging condition.

Gender

FEMALE

Eligibility criteria

• 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. Have a History of other malignancies prior to the start of study treatment.
• • 4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
• • 5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
• • 6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
• • 7. Pregnant or lactating women.
• • 8. 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; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.
• • 9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
• • 10. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \> 2,000 IU/mL or \> 10(4) copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
• • 11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
• • 12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
• • 13. Presence of uncontrolled infections before the start of study treatment.
• • 14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
• • 15. 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.