# Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Source: https://onco.cc/trials/nct05860465/  
OnCo record `nct05860465` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial testing SPH4336 in HR-positive / HER2-negative breast cancer, now recruiting.

## Summary

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer is a phase 2/3 interventional study registered as NCT05860465, led by Shanghai Pharmaceuticals, and recruiting on the registry. Official title: 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. Planned enrolment is 254 participants (estimated). The study started in 2023-09-08 and primary completion is expected in 2026-12-01. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT05860465
- Phase: 2/3
- Setting: 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
- Sponsor: Shanghai Pharmaceuticals
- Enrolled: 254

## Sources

- ClinicalTrials.gov NCT05860465: https://clinicaltrials.gov/study/NCT05860465

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- drugs: [SPH4336](https://onco.cc/drugs/sph4336/)
- companies: [Shanghai Pharmaceuticals](https://onco.cc/companies/shanghai-pharmaceuticals/)

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