Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
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
1 other identifier
interventional
254
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2023
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 16, 2023
CompletedStudy Start
First participant enrolled
September 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
January 14, 2026
August 1, 2025
3.2 years
May 8, 2023
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Objective response rate
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Approximately 3years
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 Outcomes (6)
Cmax
Approximately 3years
Tmax
Approximately 3years
Disease control rate (DCR)
Approximately 3years
Duration of remission (DOR)
Approximately 3years
Overall Survival (OS)
Approximately 8years
- +1 more secondary outcomes
Study Arms (2)
SPH4336 Tablets
EXPERIMENTALSPH4336 Tablets; Letrozole tablets; Fulvestrant injection
SPH4336 Tablets Placebo
PLACEBO COMPARATORSPH4336 Tablets Placebo; Letrozole tablets; Fulvestrant injection
Interventions
SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Liuzhou people's Hospital
Liuchow, Guangxi, 545026, China
Anyang Cancer Hospital
Anyang, He'nan, 455001, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, He'nan, 450052, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University cancer Hospital
Harbin, Heilongjiang, 150081, China
Xiangyang Cancer Hospital
Wuhan, Hubei, 441021, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110002, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750003, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061, China
The second people's hospital of neijiang
Neijiang, Sichuan, 641199, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang cancer Hospital
Hangzhou, Zhejiang, 310005, China
Peking Union Medical College Hospital
Beijing, 100730, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Fujian Cancer Hospital
Fuzhou, China
First Affiliated Hospital of Kunming Medical University
Kunming, China
Shenzhen Hospital of University of Hong Kong
Shenzhen, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 16, 2023
Study Start
September 8, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
January 14, 2026
Record last verified: 2025-08