NCT05860465 Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
| NCT ID | NCT05860465 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
| Condition | Locally Advanced or Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 254 participants |
| Start Date | 2023-09-08 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 254 participants in total. It began in 2023-09-08 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05860465 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Locally Advanced or Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05860465 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05860465 currently recruiting?
Yes, NCT05860465 is actively recruiting participants. Contact the research team at wangshs@sysucc.org.cn for enrollment information.
Where is the NCT05860465 trial being conducted?
This trial is being conducted at Guangzhou, China, Liuzhou, China, Anyang, China, Luoyang, China and 11 additional locations.
Who is sponsoring the NCT05860465 clinical trial?
NCT05860465 is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. The trial plans to enroll 254 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.