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

April 29, 2026 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Chunmei Bai
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Huiping Li
      • 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
      • Nanning, China
        • Recruiting
        • Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
        • Contact:
          • Yongkui Lu
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Yehui Shi
      • Wuhan, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Jing Yao
      • Xi'an, China
        • Recruiting
        • Xi'An International Medical Cancer Hospital
        • Contact:
          • Yan Xue
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Min Yan
    • 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:
    • Guangxi
      • Liuzhou, Guangxi, China, 545026
        • Recruiting
        • Liuzhou People's Hospital
        • Contact:
          • Bin Yu
    • He'nan
      • Anyang, He'nan, China, 455001
        • Recruiting
        • Anyang Cancer Hospital
        • Contact:
          • Jing Sun
      • Luoyang, He'nan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Xinshuai Wang
    • 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
    • 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
      • Ürümqi, 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intracranial Objective response rate（iORR）
Time Frame: Approximately 3 years
Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.
Approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intracranial Duration of remission (iDOR)
Time Frame: Approximately 3 years
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)
Time Frame: Approximately 3 years
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)
Time Frame: Approximately 3 years
measured by RANO-BM and RECIST 1.1
Approximately 3 years
Overall Survival (OS)
Time Frame: Approximately 8 years
Determination of the overall survival times of all patients.
Approximately 8 years
Extracranial Objective response rate（eORR）
Time Frame: Approximately 3 years
Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.
Approximately 3 years
Extracranial Disease control rate (eDCR)
Time Frame: Approximately 3 years
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)
Time Frame: Approximately 3 years
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
Time Frame: Approximately 3 years
PK (Pharmacokinetics) parameters
Approximately 3 years
Tmax
Time Frame: Approximately 3 years
PK (Pharmacokinetics) parameters
Approximately 3 years
Safety and tolerability
Time Frame: Approximately 3 years
Adverse event type, incidence, correlation with study drug
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pharmaceuticals Holding Co., Ltd

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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