A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with apatinib and chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Newly diagnosed breast cancer.
• 18-75 Years, female.
• Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
• Tumor stage: II-III.
• ECOG Performance Status of 0-1.
• life expectancy is not less than 3 months.
• at least one measurable lesion according to RECIST 1.1.
• Adequate hematologic and organ function.
• Must be willing to use an adequate method of contraception for the course of the study.
Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Ting Luo, MD
tina621@163.com
+86 18602866299
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 35
Treatments
Experimental: Camrelizumab + Apatinib + Chemotherapy
Participants received neoadjuvant therapy with four 4-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and nab-paclitaxel (125 mg/m2, qw), followed by four 2-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and epirubicin (90 mg/m2, q2w) + cyclophosphamide (600 mg/m2, q2w).
Related Therapeutic Areas
Sponsors
Leads: West China Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.