New treatment for advanced breast cancer using SPH4336 and letrozole

Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

This study is testing if a new treatment combining SPH4336 with letrozole can help women with advanced breast cancer feel better compared to just taking letrozole with a placebo.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 374 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (industry)
• Locations: 9 sites (Fuzhou, Fujian and 8 other locations)
• Trial ID: NCT05744687 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal or premenopausal/perimenopausal women aged 18 to 75 with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer.

Not a fit: Patients with previously treated locally advanced or metastatic breast cancer or those who can undergo radical surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for women with advanced breast cancer who cannot undergo radical surgeries.

How similar studies have performed: Other studies have shown promise in using targeted therapies for breast cancer, but the specific combination of SPH4336 and letrozole is relatively novel.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian and 8 other locations

• 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)
• The Second Norman Bethune Hospital of Jilin Univer — Changchun, Jilin, China (RECRUITING)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (RECRUITING)
• Peking University Cancer Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Shusen Wang

Conditions: Locally Advanced or Metastatic Breast Cancer