A Multicenter Phase II Clinical Study of Pyrotinib Combined With Dalpiciclib Combined With Letrozole in the Treatment of ER-positive and HER2-positive Advanced Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. The sample size is 63.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• The subjects voluntarily joined the study, signed the informed consent, and had good compliance
• Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years
• Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression
• Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria
• At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer
Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Zhiqiang Xiao, Master
zhiqiang.xiao@hengrui.com
17757194561
Backup
Zhiqiang Xiao
zhiqiang.xiao@hengrui.com
17757194561
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 63
Treatments
Experimental: pyrotinib dalpiciclib letrozole
Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Cancer Hospital