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Using SPH4336 with hormone therapy for advanced 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

Phase2; Phase3 Interventional Shanghai Pharmaceuticals Holding Co., Ltd · NCT05860465

This study is testing a new treatment called SPH4336 combined with hormone therapy to see if it helps people with advanced breast cancer that hasn't responded to other treatments.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment254 (estimated)
Ages18 Years to 75 Years
SexFemale
SponsorShanghai Pharmaceuticals Holding Co., Ltd Industry-sponsored
Locations22 sites (Guangzhou, Guangdong and 21 other locations)
Trial IDNCT05860465 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of SPH4336, a new treatment, in combination with endocrine therapy for patients with locally advanced or metastatic breast cancer that has progressed after treatment with CDK4/6 inhibitors. The trial includes both Phase 2 and Phase 3 components to assess the drug's effectiveness and safety profile. Participants must have measurable lesions and meet specific health criteria to be eligible for the study.

Who should consider this trial

Good fit: Ideal candidates are patients with locally advanced or metastatic breast cancer who have not responded to previous treatments and are unable to undergo radical surgeries.

Not a fit: Patients with inflammatory breast cancer or those who are 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 patients with advanced breast cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific combination of SPH4336 with endocrine therapy is being evaluated for the first time.

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. History of other malignancies prior to the start of study treatment.
4. Patients with known metastases to central nervous system.
5. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
6. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
7. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
8. Pregnant or lactating women.
9. 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.
10. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
11. 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.
12. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
13. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
14. Presence of uncontrolled infections before the start of study treatment.
15. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
16. 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

Guangzhou, Guangdong and 21 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 Locally Advanced or Metastatic Breast Cancer
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.