NCT04498793

Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer

Study of Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as Perioperative Treatment in Participants With HER2 Negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of tislelizumab plus chemotherapy vs chemotherapy alone as perioperative treatment in participants who have triple negative HER2 negative breast cancer. After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Tislelizumab + Chemotherapy OR Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (routine adjuvant treatment +/- Tislelizumab) for approximately 42 weeks (14 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

Conditions

• HER2-negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tislelizumab	On Day 1 of the last seven cycles in the neoadjuvant and each cycle in the adjuvant phases of the study for a total of 21 cycles; intravenous (IV) infusion.
DRUG	Nab paclitaxel	On Days 1 and 8 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
DRUG	Doxorubicin	On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
DRUG	Epirubicin	On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
DEVICE	Cyclophosphamide	On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2020-08-04
• Last updated: 2020-09-03

Locations

2 sites across 1 country: China