Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
• Hormone receptor (HR)-positive and HER2-positive.
• Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
• ECOG Performance Status: 0-1.
Locations
Other Locations
China
Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District
RECRUITING
Guangdong
Contact Information
Primary
Chen Doctor Chen, PhD / Doctorate
chenmt@sysucc.org.cn
02087341812
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2029-11-01
Participants
Target number of participants: 57
Treatments
Experimental: Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University