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

NCT05843292 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-06-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Innovent Biologics, Inc.

    collaborator OTHER

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-12-31
Completion
2034-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843292 on ClinicalTrials.gov