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Combining SPH4336 with endocrine therapy for breast cancer patients with brain metastases

A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.

Phase 2 Interventional Shanghai Pharmaceuticals Holding Co., Ltd · NCT05872347

This study is testing if adding SPH4336 tablets to hormone therapy can help breast cancer patients with brain metastases feel better when other treatments aren't an option.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment52 (estimated)
Ages18 Years to 75 Years
SexFemale
SponsorShanghai Pharmaceuticals Holding Co., Ltd Industry-sponsored
Locations25 sites (Hefei, Anhui and 24 other locations)
Trial IDNCT05872347 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of SPH4336 tablets when used alongside endocrine therapy in patients suffering from breast cancer that has spread to the brain. It aims to determine how well this combination treatment works for patients who are not candidates for radical surgeries or other local therapies. Participants must have measurable lesions and meet specific health criteria to ensure their safety during the trial.

Who should consider this trial

Good fit: Ideal candidates include patients with locally advanced or metastatic breast cancer who have brain metastases and are unable to undergo radical surgery.

Not a fit: Patients with inflammatory breast cancer or those unsuitable for endocrine therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for breast cancer patients with brain metastases, potentially improving their outcomes.

How similar studies have performed: While there is ongoing research in this area, the specific combination of SPH4336 with endocrine therapy in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Hefei, Anhui and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancer Brain Metastases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.