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.

Trial Details

NCT ID

NCT07207070

Phase

PHASE3

Sponsor

Risen (Suzhou) Pharma Tech Co., Ltd.

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

• JS105
• Dalpiciclib
• Fulvestrant 50 Mg/mL Intramuscular Solution

Locations (sample)

• Beijing, Beijing Municipality, China|39.9075,116.39723
• Zhengzhou, Henan, China|34.75778,113.64861

Key Eligibility Criteria

• At the time of signing the consent form, age must be between 18 and 75 years old, males and females;
• Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer;
• Consent to provide tumour tissue or blood samples to determine the PIK3CA mutation status;
• ECOG 0 or 1;

For full eligibility, visit ClinicalTrials.gov.

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