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Breast Cancer Brain MetastasesPhase 2NCT05872347

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

A Phase 2 study testing SPH4336 Tablets in people with Breast Cancer Brain Metastases, run by Shanghai Pharmaceuticals Holding Co., Ltd at 25 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer Brain Metastases
What is being tested?
SPH4336 Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
25 sitesChina
Study dates
19 Sep 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Inflammatory breast cancer.
  • Patients unsuitable for endocrine therapy at the investigator's discretion.
  • Have a History of other malignancies prior to the start of study treatment.
  • 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.
Show all 15Show fewer
  • 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; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.
  • 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 > 10(4) 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shusen Wang contact

0086-020-87343811

wangshs@sysucc.org.cn

25 sites in 1 country

China25 sites, 25 recruiting

  • Anyang Cancer Hospital

    Anyang, He'nan, 455001

    Jing Sun

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Chunmei Bai

    Recruiting

  • Beijing Cancer Hospital

    Beijing

    Huiping Li

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

    Gongsheng Jin

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

    Ying Cheng

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130061

    Jiuwei Cui

    Recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing, 404031

    Chao Deng

    Recruiting

  • Affiliated Cancer Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Shusen Wang, 0086-020-87343811, wangshs@sysucc.org.cn

    Recruiting

  • Zhejiang cancer Hospital

    Hangzhou, Zhejiang, 310005

    Zhanhong Chen

    Recruiting

  • Harbin Medical University cancer Hospital

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang

    Recruiting

  • Anhui provincial hospital

    Hefei, Anhui, 230002

    Yueyin Pan

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Yingying Du

    Recruiting

  • Liuzhou people's Hospital

    Liuzhou, Guangxi, 545026

    Bin Yu

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, He'nan, 450052

    Xinshuai Wang

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Yongmei Yin

    Recruiting

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    Nanning

    Yongkui Lu

    Recruiting

  • The second people's hospital of neijiang

    Neijiang, Sichuan, 641199

    Xujuan Wang

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Cuizhi Geng

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Yehui Shi

    Recruiting

  • Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Bing Zhaoi

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Jing Yao

    Recruiting

  • Xi'An International Medical Cancer Hospital

    Xi'an

    Yan Xue

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

    Yuehua Wang

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

    Xinlan Liu

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Min Yan

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
SPH4336 Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPH4336 TabletsDrug

    SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral.

Study groups in NCT05872347
Study groupRoleWhat they receive
SPH4336 TabletsExperimentalSPH4336 Tablets; Letrozole tablets; Fulvestrant; Exemestane
Receives: Drug: SPH4336 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial Objective response rate（iORR）

    Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.

    Measured: Approximately 3 years

Secondary outcomes (10)

  1. Intracranial Duration of remission (iDOR)

    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.

    Measured: Approximately 3 years

  2. Intracranial Disease control rate (iDCR)

    Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.

    Measured: Approximately 3 years

  3. Progression-free survival (PFS)

    measured by RANO-BM and RECIST 1.1

    Measured: Approximately 3 years

  4. Overall Survival (OS)

    Determination of the overall survival times of all patients.

    Measured: Approximately 8 years

  5. Extracranial Objective response rate（eORR）

    Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.

    Measured: Approximately 3 years

  6. Extracranial Disease control rate (eDCR)

    Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.

    Measured: Approximately 3 years

  7. Extracranial Duration of remission (eDOR)

    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.

    Measured: Approximately 3 years

  8. Cmax

    PK (Pharmacokinetics) parameters

    Measured: Approximately 3 years

  9. Tmax

    PK (Pharmacokinetics) parameters

    Measured: Approximately 3 years

  10. Safety and tolerability

    Adverse event type, incidence, correlation with study drug

    Measured: Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start19 Sep 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05872347
Sponsor's protocol ID
SPH4336-202
Status last verified
Aug 2025
First submitted
14 May 2023
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SPH4336 Tablets in people with Breast Cancer Brain Metastases, run by Shanghai Pharmaceuticals Holding Co., Ltd at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shusen Wang (0086-020-87343811, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Objective response rate（iORR） (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05872347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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