NCT05843292: NeoSTEP

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

Not yet recruiting Phase 4 Last updated 6 June 2023

What this trial tests

Phase 4 trial testing Taxane and Carboplatin in Triple-negative Breast Cancer in 48 participants. Not yet recruiting.

Timeline

1 July 2023

Primary endpoint
31 December 2024

31 December 2034

Quick facts

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 July 2023
Primary completion	31 December 2024
Estimated completion	31 December 2034

Drugs / interventions tested

• Taxane and Carboplatin — full drug profile →
• Short-term Sintilimab — full drug profile →
• Surgery

Conditions studied

• Triple-negative Breast Cancer — all drugs for Triple-negative Breast Cancer →

Sponsor

Shanghai Jiao Tong University School of Medicine

Who can join

Adults 18 to 70, female only, with Triple-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy and its racial specificity for breast cancer treatment in Asia: a narrative review.
   Xu RC, Zhang YW, Liu CC, Xu YY, et al · · 2025 · cited 3× · PMID 40443538 · DOI 10.1016/j.lanwpc.2024.101180
2. Breast Cancer: Molecular Pathogenesis, Targeted Therapy, Screening, and Prevention.
   Lei H, Fu J, Gu W, Qiao H, et al · · 2026 · PMID 41510186 · DOI 10.1002/mco2.70560