New treatment for advanced breast cancer using SPH4336 and letrozole

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 effectiveness of SPH4336 in combination with letrozole as a first-line treatment for patients with locally advanced or metastatic breast cancer. It aims to determine whether this combination can improve patient outcomes compared to a placebo combined with letrozole. Eligible participants include women aged 18 to 75 with specific hormone receptor statuses and measurable lesions. The study will involve multiple locations in China to gather diverse data on the treatment's efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
2. Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
3. ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.
4. Life expectancy ≥ 3 months.
5. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies, with hormone receptor positive and human epidermal growth factor receptor 2 negative confirmed by tumor histopathology and molecular pathology.
6. No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries/other local therapies.
7. At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.
8. Postmenopausal or premenopausal/perimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.
9. Laboratory test results before randomization meet the relevant requirements for organ function.

Exclusion Criteria:

1. Prior treatment with any CDK4/6 （Cyclin dependent kinase）inhibitor.
2. Inflammatory breast cancer.
3. Patients unsuitable for endocrine therapy at the investigator's discretion.
4. History of other malignancies within 5 years prior to the start of study treatment.
5. Patients with known central nervous system metastases.
6. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
7. Having undergone a surgery within 28 days prior to the start of study treatment, and hasn't yet recovered from adverse reactions of the surgery.
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; LVEF(Left Ventricular Ejection Fractions)≤ 50%.
9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
10. Being receiving potent CYP3A4 inhibitors or inducers at the time of signing the ICF.
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. Patients who participated in a clinical trial and received other investigational drugs within 30 days before the start of study treatment.
13. History of severe anaphylactic diseases, history of severe drug allergy, or known allergy to any ingredient of the investigational product.
14. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.
15. Uncontrolled infections within 2 weeks before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.
16. Pregnant or lactating women.
17. Known history of substance abuse, excessive drinking, or illegal drug addiction; history of confirmed neurological or mental disorders.
18. Presence of other diseases judged by the investigator that the risks of receiving the study treatment outweigh its benefits, or any other reason for which patients are ineligible for the study as assessed by the investigator and the sponsor.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Affiliated Cancer Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Affiliated Cancer Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Recruiting
• AnYang Tumor Hospital
  Anyang, Henan, China Recruiting
• The First Affiliated Hospital of Henan University of Science and Technology
  Luoyang, Henan, China Recruiting
• Pingxiang People's Hospital
  Pingxiang, Jiangxi, 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.