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

Study acronym: NeoSTEP
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 6, 2023 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date: May 1, 2023 to Jul 1, 2023v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05843292
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators: Innovent Biologics, Inc., CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Triple-negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov