Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Locally Advanced or Metastatic Breast Cancer Clinical Trial

Official title:

A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860465
• Other study ID #: SPH4336-302
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 8, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: May 2023
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: Shusen Wang
• Phone: 0086-020-87343811
• Email: wangshs[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: August 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced or Metastatic Breast Cancer

Intervention

Drug:
• SPH4336 Tablets
SPH4336 Tablets :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion
• SPH4336 Tablets Placebo
SPH4336 Tablets Placebo :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	Henan
China	Peking Union Medical College Hospital	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu
China	Jilin Cancer Hospital	Changchun	Jilin
China	Fujian Cancer Hospital	Fuzhou
China	Affiliated Cancer Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Zhejiang cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University cancer Hospital	Harbin	Heilongjiang
China	First Affiliated Hospital of Kunming Medical University	Kunming
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	Liuzhou people's Hospital	Liuzhou	Guangxi
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The second people's hospital of neijiang	Neijiang	Sichuan
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen Hospital of University of Hong Kong	Shenzhen
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Xiangyang Cancer Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shanxi
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.	Approximately 3years
Primary	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	Cmax	PK (Pharmacokinetics) parameters	Approximately 3years
Secondary	Tmax	PK (Pharmacokinetics) parameters	Approximately 3years
Secondary	Disease control rate (DCR)	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease	Approximately 3years
Secondary	Duration of remission (DOR)	DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause	Approximately 3years
Secondary	Overall Survival (OS)	Determination of the overall survival times of all patients	Approximately 8years
Secondary	Safety and tolerability of the combination therapy since the start of any study treatment.	Adverse event type, incidence, duration, correlation with study drug	Approximately 3years