NCT05843292

Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer

Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer, an Open-labeled, Single Arm Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the efficacy and safety of short-term sintilimab in combination with taxane and carboplatin for neoadjuvant therapy in female early-stage triple-negative breast caner patients aging from 18 to 70 years with unilateral and invasive primary lesions above 1cm. The main questions it aims to answer are: 1. Does short-term sintilimab in combination with taxane and carboplatin lead to acceptible pathological complete response (pCR) rates, objective response rates (ORR), event-free survival (EFS) and overall survival (OS)? 2. Does short-term sintilimab in combination with taxane and carboplatin lead to less adverse events than regular-term ICIs reported in literature? Participants will be given 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin before surgery. An optional core-needle biopsy is performed after completing 2 cycles of sintilimab. All participants will be given regular follow-up post surgery according to ASCO guidelines.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Taxane and Carboplatin	Nab-paclitaxel 100mg/m2+ Carboplatin AUC2 by intravenous (IV) infusion on day1, day8 and day15, every 4 weeks, for 4 cycles. or Docetaxel 75mg/m2+ Carboplatin AUC5 by intravenous (IV) infusion on day1, every 3 weeks, for 4 cycles. or Paclitaxel 80mg/m2+ Carboplatin AUC2 by intravenous (IV) infusion on day1, day8 and day15, every 4 weeks, for 4 cycles.
DRUG	Short-term Sintilimab	Sintilimab 200mg by intravenous (IV) infusion on day1, every 3 weeks, for 2 cycles.
PROCEDURE	Surgery	All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-31
• Completion: 2034-12-31
• First posted: 2023-05-06
• Last updated: 2023-06-06