Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

NCT05744687 | Recruiting Phase 2

• 1 other identifier: SPH4336-301
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 9

Brief Summary

This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer

Conditions

Locally Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• response rate (ORR)

  tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

  Approximately 3years

• Progression-free survival (PFS)

  from the start date of study treatment to the date of progression disease or death , whichever occurred first.

  Approximately 3years

Secondary Outcomes (6)

• Cmax

  Approximately 3years

• Tmax

  Approximately 3years

• Disease control rate (DCR)

  Approximately 3years

• Duration of remission (DOR)

  Approximately 3years

• Overall Survival (OS)

  Approximately 8years

Study Arms (2)

SPH4336 Tablets 400mg

EXPERIMENTAL

SPH4336 Tablets； Letrozole tablets

Drug: SPH4336 Tablets 400mg

SPH4336 Tablets Placebo

PLACEBO COMPARATOR

SPH4336 Placebo； Letrozole tablets

Drug: SPH4336 Tablets Placebo

Interventions

SPH4336 Tablets 400mg DRUG

SPH4336 Tablets ：Orally, 400mg once a day; 28 days/cycle Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle

SPH4336 Tablets 400mg

SPH4336 Tablets Placebo DRUG

SPH4336 Tablets Placebo：Orally,28 days/cycle Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle

SPH4336 Tablets Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
• Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
• ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.
• Life expectancy ≥ 3 months.
• 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.
• No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries/other local therapies.
• At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.
• Postmenopausal or premenopausal/perimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.
• Laboratory test results before randomization meet the relevant requirements for organ function.

You may not qualify if:

• Prior treatment with any CDK4/6 （Cyclin dependent kinase）inhibitor.
• Inflammatory breast cancer.
• Patients unsuitable for endocrine therapy at the investigator's discretion.
• History of other malignancies within 5 years prior to the start of study treatment.
• Patients with known central nervous system metastases.
• Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
• 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.
• 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%.
• History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
• Being receiving potent CYP3A4 inhibitors or inducers at the time of signing the ICF.
• 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.
• Patients who participated in a clinical trial and received other investigational drugs within 30 days before the start of study treatment.
• History of severe anaphylactic diseases, history of severe drug allergy, or known allergy to any ingredient of the investigational product.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (9)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

AnYang Tumor Hospital

Anyang, Henan, 455001, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 450052, China

RECRUITING

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337099, China

RECRUITING

The Second Norman Bethune Hospital of Jilin Univer

Changchun, Jilin, 130022, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750003, China

RECRUITING

Peking University Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Shusen Wang

CONTACT

0086-020-87343811; wangshs@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: April 24, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

CN (9)