# Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

Source: https://onco.cc/trials/nct05744687/  
OnCo record `nct05744687` (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

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer is a phase 2/3 interventional study registered as NCT05744687, led by Shanghai Pharmaceuticals, and recruiting on the registry. Official title: Randomised, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer. Planned enrolment is 374 participants (estimated). The study started in 2023-04-24 and primary completion is expected in 2026-05-31. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT05744687
- Phase: 2/3
- Setting: Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
- Sponsor: Shanghai Pharmaceuticals
- Enrolled: 374

## Sources

- ClinicalTrials.gov NCT05744687: https://clinicaltrials.gov/study/NCT05744687

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [SPH4336](https://onco.cc/drugs/sph4336/)
- companies: [Shanghai Pharmaceuticals](https://onco.cc/companies/shanghai-pharmaceuticals/)

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