- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05860465
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
March 21, 2024 updated by: Shanghai Pharmaceuticals Holding Co., Ltd
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
254
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shusen Wang
- Phone Number: 0086-020-87343811
- Email: wangshs@sysucc.org.cn
Study Locations
-
-
-
Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Chunmei Bai
-
Bengbu, China
- Recruiting
- the First Affiliated Hospital of Bengbu Medical College
-
Contact:
- Jun Qian
-
Fuzhou, China
- Recruiting
- Fujian Cancer Hospital
-
Contact:
- Weiwei Huang
-
Kunming, China
- Recruiting
- First Affiliated Hospital of Kunming Medical University
-
Contact:
- Jinxian Qian
-
Shenzhen, China
- Recruiting
- Shenzhen Hospital of University of Hong Kong
-
Contact:
- Haiman Jing
-
-
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
-
Wuhan, Hubei, China, 441021
- Recruiting
- Xiangyang Cancer Hospital
-
Contact:
- Yuehua Wang
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- Jiangsu Cancer Hospital
-
Contact:
- Jifeng Feng
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- Jiangsu Province Hospital
-
Contact:
- Yongmei Yin
-
-
Jilin
-
Changchun, Jilin, China, 130012
- Recruiting
- Jilin Cancer Hospital
-
Contact:
- Ying Cheng
-
-
Liaoning
-
Shenyang, Liaoning, China, 110002
- Recruiting
- The First Hospital of China Medical University
-
Contact:
- Yue'e Teng
-
-
Ningxia
-
Yinchuan, Ningxia, China, 750003
- Recruiting
- General Hospital of Ningxia Medical University
-
Contact:
- Xinlan Liu
-
-
Shanxi
-
Xi'an, Shanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiao Tong University
-
Contact:
- Jin Yang
-
-
Sichuan
-
Neijiang, Sichuan, China, 641199
- Recruiting
- The second people's hospital of neijiang
-
Contact:
- Xujuan Wang
-
-
Yunnan
-
Kunming, Yunnan, China, 650118
- Recruiting
- Yunnan Cancer Hospital
-
Contact:
- Jianyun Nie
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310005
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Zhanhong Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
- ECOG (Eastern Cooperative Oncology Group) performance status score of 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.
- At least one measurable lesion.
- Laboratory test results meet the relevant requirements for organ function.
- Subjects who agree to take effective contraceptive measures.
Exclusion Criteria:
- Inflammatory breast cancer.
- Patients unsuitable for endocrine therapy at the investigator's discretion.
- History of other malignancies prior to the start of study treatment.
- Patients with known metastases to central nervous system.
- Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
- Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
- Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
- Pregnant or lactating women.
- 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.
- History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
- 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.
- History of severe allergic diseases, history of severe drug allergies, 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.
- Presence of uncontrolled infections before the start of study treatment.
- Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SPH4336 Tablets
SPH4336 Tablets; Letrozole tablets; Fulvestrant injection
|
SPH4336 Tablets :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion
|
Placebo Comparator: SPH4336 Tablets Placebo
SPH4336 Tablets Placebo; Letrozole tablets; Fulvestrant injection
|
SPH4336 Tablets Placebo :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Approximately 3years
|
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
|
Approximately 3years
|
Objective response rate
Time Frame: Approximately 3years
|
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
|
Approximately 3years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: Approximately 3years
|
PK (Pharmacokinetics) parameters
|
Approximately 3years
|
Tmax
Time Frame: Approximately 3years
|
PK (Pharmacokinetics) parameters
|
Approximately 3years
|
Disease control rate (DCR)
Time Frame: Approximately 3years
|
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
|
Approximately 3years
|
Duration of remission (DOR)
Time Frame: Approximately 3years
|
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
|
Overall Survival (OS)
Time Frame: Approximately 8years
|
Determination of the overall survival times of all patients
|
Approximately 8years
|
Safety and tolerability of the combination therapy since the start of any study treatment.
Time Frame: Approximately 3years
|
Adverse event type, incidence, duration, correlation with study drug
|
Approximately 3years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2023
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
August 30, 2025
Study Registration Dates
First Submitted
May 8, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 16, 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
Other Study ID Numbers
- SPH4336-302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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