NCT06788197

A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients

A Phase Ib/II Study of SHR-A1811 and Fulvestrant in Combination With or Without HS-10352 in Locally Advanced or Metastatic Breast Cancer Patients Who Progressed After Adjuvant Therapy

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352.

Detailed description

This study plans to enroll breast cancer patients whose disease progressed during treatment or within 12 months of completing adjuvant therapy and who have not received prior systemic therapy. SHR-A1811 + fulvestrant group will receive treatment with SHR-A1811 and fulvestrant. HS-10352 group will receive treatment with SHR-A1811, fulvestrant, and HS-10352. Treatment will continue until disease progression or the occurrence of intolerable toxicity.

Conditions

• Breast Cancer
• Locally Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811+ Fulvestrant	SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular
DRUG	SHR-A1811+ Fulvestrant+HS-10352	SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular ； HS-10351 is administered orally

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2025-01-23
• Last updated: 2025-03-26