Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Brain Metastases
• Intervention / Treatment: Drug: SPH4336 Tablets

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shusen Wang; Phone Number: 0086-020-87343811; Email: wangshs@sysucc.org.cn

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Chunmei Bai
  • Bengbu, China
    • Recruiting
    • The First Affiliated Hospital of Bengbu Medical College
    • Contact: Gongsheng Jin
  • Chongqing, China, 404031
    • Recruiting
    • Chongqing University Three Gorges Hospital
    • Contact: Chao Deng
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The First affiliated Hospital of Anhui Medical University
      • Contact: Yingying Du
    • Hefei, Anhui, China, 230002
      • Recruiting
      • Anhui Provincial Hospital
      • Contact: Yueyin Pan
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Affiliated Cancer Hospital, Sun Yat-sen University
      • Contact: Shusen Wang; Phone Number: 0086-020-87343811; Email: wangshs@sysucc.org.cn
  • Guangxi
    • Liuzhou, Guangxi, China, 545026
      • Recruiting
      • Liuzhou people's Hospital
      • Contact: Bin Yu
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Cuizhi Geng
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Qingyuan Zhang
  • Henan
    • Anyang, Henan, China, 455001
      • Recruiting
      • Anyang Cancer Hospital
      • Contact: Jing Sun
    • Luoyang, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Xinshuai Wang
  • Hubei
    • Xiangyang, Hubei, China, 441021
      • Recruiting
      • Xiangyang Central Hospital
      • Contact: Yuehua Wang
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Yongmei Yin
  • Jilin
    • Changchun, Jilin, China, 130012
      • Recruiting
      • Jilin cancer hospital
      • Contact: Ying Cheng
    • Changchun, Jilin, China, 130061
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Jiuwei Cui
  • Ningxia
    • Yinchuan, Ningxia, China, 750003
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Xinlan Liu
  • Sichuan
    • Neijiang, Sichuan, China, 641199
      • Recruiting
      • The Second People's Hospital of Neijiang
      • Contact: Xujuan Wang
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • Recruiting
      • Cancer Hospital of Xinjiang Medical University
      • Contact: Bing Zhaoi
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Zhanhong Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. Have a History of other malignancies prior to the start of study treatment.
4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
7. Pregnant or lactating women.
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; left ventricular ejection fraction ≤ 50%.
9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
10. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA > 2,000 IU/mL or > 10(4) copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
13. Presence of uncontrolled infections before the start of study treatment.
14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPH4336 Tablets; SPH4336 Tablets; Letrozole tablets; Fulvestrant; Exemestane	Drug: SPH4336 Tablets; SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial Objective response rate（iORR）	Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.	Approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial Duration of remission (iDOR)	DoR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause.	Approximately 3 years
Intracranial Disease control rate (iDCR)	Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.	Approximately 3 years
Progression-free survival (PFS)	measured by RANO-BM and RECIST 1.1	Approximately 3 years
Overall Survival (OS)	Determination of the overall survival times of all patients.	Approximately 8 years
Extracranial Objective response rate（eORR）	Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.	Approximately 3 years
Extracranial Disease control rate (eDCR)	Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.	Approximately 3 years
Extracranial Duration of remission (eDOR)	DoR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause.	Approximately 3 years
Cmax	PK (Pharmacokinetics) parameters	Approximately 3 years
Tmax	PK (Pharmacokinetics) parameters	Approximately 3 years
Safety and tolerability	Adverse event type, incidence, correlation with study drug	Approximately 3 years

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: SPH4336-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No