The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

September 15, 2021

Primary Completion Date

August 31, 2023

Study Completion Date

December 31, 2025

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Sintilimab

200mg on days 1 (Q3W) of the neoadjuvant and adjuvant phase of the study; IV injection.

DRUG

Anlotinib

12mg on d1-14 of Cycles 1-8 (Q3W) of the neoadjuvant phase of the study; po. Arotinib is a small molecule multi-target TKI, which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.

DRUG

Nab paclitaxel

100 mg/m² on day 1, 8 and 15 of Cycles 1-4 (Q3W) of the neoadjuvant phase of the study; IV injection.

DRUG

Carboplatin

AUC 5 on days 1 of Cycles 1-4 (Q3W) of the neoadjuvant phase of the study; IV injection.

DRUG

Epirubicin

90 mg/m² on day of Cycles 5-8 (Q3W) of the neoadjuvant phase of the study; IV injection.

DRUG

Cyclophosphamide

600 mg/m² on day of Cycles 5-8 (Q3W) of the neoadjuvant phase of the study; IV injection.

Trial Locations (1)

510080

NeoSACT, Guangzhou

All Listed Sponsors
lead

Guangdong Provincial People's Hospital

OTHER