Trial Title:
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
NCT ID:
NCT05744687
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:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
SPH4336 Tablets 400mg
Description:
SPH4336 Tablets ：Orally, 400mg once a day; 28 days/cycle
Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle
Arm group label:
SPH4336 Tablets 400mg
Intervention type:
Drug
Intervention name:
SPH4336 Tablets Placebo
Description:
SPH4336 Tablets Placebo：Orally,28 days/cycle
Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle
Arm group label:
SPH4336 Tablets Placebo
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
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Liu
Phone:
0086-0591-62752181
Email:
fjszlyyjgb@163.com
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:
The Affiliated Cancer Hospital of Guizhou Medical University
Address:
City:
Guiyang
Zip:
550000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihong Wang
Phone:
0086-0851-86501211
Email:
1453260207@qq.com
Facility:
Name:
AnYang Tumor Hospital
Address:
City:
Anyang
Zip:
455001
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Sun
Phone:
0086-0372-2233016
Email:
ayzlyy@163.com
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
Phone:
0086-0379-64922216
Email:
Hkdyfyllb@163.com
Facility:
Name:
Renmin Hospital of Wuhan University Hubei General Hospital
Address:
City:
Wuhan
Zip:
430060
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Yao
Phone:
0086-027-88328261
Email:
czhyshjjb@yahoo.com.cn
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215004
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhixiang Zhuang
Phone:
0086-0512-67783682
Email:
sdfeyec@163.com
Facility:
Name:
Pingxiang People's Hospital
Address:
City:
Pingxiang
Zip:
337099
Country:
China
Status:
Recruiting
Contact:
Last name:
An Xiao
Phone:
0086-0799-6882099
Facility:
Name:
The Second Norman Bethune Hospital of Jilin Univer
Address:
City:
Chang chun
Zip:
130022
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingwei Xu
Phone:
0086-0431-81136334
Email:
1312600916@qq.com
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Yinchuan
Zip:
750003
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinlan Liu
Phone:
0086-0951-6743648
Email:
nydzyec@126.com
Facility:
Name:
Tai'an Central Hospital
Address:
City:
Tai'an
Zip:
271099
Country:
China
Status:
Recruiting
Contact:
Last name:
Baojiang Li
Phone:
0086-0538-2199516
Email:
taychz@163.com
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiping Li
Phone:
0086-010-88121122
Email:
huipingli2012@hotmail.com
Facility:
Name:
Tianjin Medical University cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Recruiting
Contact:
Last name:
Weipeng Zhao
Phone:
0086-022-23340123
Email:
XXJLB@tjmuch.com
Start date:
April 24, 2023
Completion date:
December 16, 2024
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/NCT05744687
