Clinical Trial: NCT04877821
The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Guangdong Provincial People's Hospital |
| Information Provided By: | Guangdong Provincial People's Hospital |
| Last Update Posted: | 2026-04-02 |
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab plus anlotinib combined with chemotherapy as neoadjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Sintilimab + anlotinib + chemotherapy) based on schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 4-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary outcome measure is pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0.
Official Title
Conditions
Intervention / Treatment
- Drug: Sintilimab
- Drug: Anlotinib
- Drug: Nab paclitaxel
- Drug: Carboplatin
- Drug: Epirubicin
- Drug: Cyclophosphamide
Other Study ID Numbers
- 2021-19
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Guangdong Provincial People's Hospital |
| Information Provided By: | Guangdong Provincial People's Hospital |
| Last Update Posted: | 2026-04-02 |
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab plus anlotinib combined with chemotherapy as neoadjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Sintilimab + anlotinib + chemotherapy) based on schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 4-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary outcome measure is pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0.
Official Title
Conditions
Intervention / Treatment
- Drug: Sintilimab
- Drug: Anlotinib
- Drug: Nab paclitaxel
- Drug: Carboplatin
- Drug: Epirubicin
- Drug: Cyclophosphamide
Other Study ID Numbers
- 2021-19