# A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

> **NCT07207070** · PHASE3 · RECRUITING · sponsor: **Risen (Suzhou) Pharma Tech Co., Ltd.** · enrollment: 312 (estimated)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** JS105
- **DRUG:** Dalpiciclib
- **DRUG:** Fulvestrant 50 Mg/mL Intramuscular Solution

## Key facts

- **NCT ID:** NCT07207070
- **Lead sponsor:** Risen (Suzhou) Pharma Tech Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-11-12
- **Primary completion:** 2029-05-31
- **Final completion:** 2030-05-31
- **Target enrollment:** 312 (ESTIMATED)
- **Last updated:** 2025-12-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07207070

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07207070, "A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT07207070. Licensed CC0.

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