Trial Title:
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
NCT ID:
NCT05860465
Condition:
Locally Advanced or Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
SPH4336 Tablets
Description:
SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral;
Fulvestrant injection：Administered by intravenous infusion
Arm group label:
SPH4336 Tablets
Intervention type:
Drug
Intervention name:
SPH4336 Tablets Placebo
Description:
SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral;
Fulvestrant injection：Administered by intravenous infusion
Arm group label:
SPH4336 Tablets Placebo
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Cancer Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Shusen Wang
Phone:
0086-020-87343811
Email:
wangshs@sysucc.org.cn
Facility:
Name:
Liuzhou people's Hospital
Address:
City:
Liuzhou
Zip:
545026
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Yu
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Cuizhi Geng
Facility:
Name:
Harbin Medical University cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingyuan Zhang
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Zip:
455001
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Sun
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinshuai Wang
Facility:
Name:
Xiangyang Cancer Hospital
Address:
City:
Wuhan
Zip:
441021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuehua Wang
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Jifeng Feng
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongmei Yin
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Recruiting
Contact:
Last name:
Yue'e Teng
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Yinchuan
Zip:
750003
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinlan Liu
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiao Tong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Yang
Facility:
Name:
The second people's hospital of neijiang
Address:
City:
Neijiang
Zip:
641199
Country:
China
Status:
Recruiting
Contact:
Last name:
Xujuan Wang
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianyun Nie
Facility:
Name:
Zhejiang cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhanhong Chen
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunmei Bai
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Qian
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiwei Huang
Facility:
Name:
First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinxian Qian
Facility:
Name:
Shenzhen Hospital of University of Hong Kong
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiman Jing
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Yehui Shi
Start date:
September 8, 2023
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Pharmaceuticals Holding Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05860465
