Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Docetaxel

Albumin-Bound Paclitaxel

Taxane

Prior to surgery: 2 cycles of sintilimab, in combination with 4 cycles of 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.

Taxane and Carboplatin

Sintilimab 200mg by intravenous (IV) infusion on day1, every 3 weeks, for 2 cycles.

Short-term Sintilimab

All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Surgery

Jiayi Wu

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.

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

The percentage of participants who experienced at least one adverse event during study treatment.

The percentage of participants with the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer \[AJCC\] staging system).

The percentage of participants with complete response (CR) and partial response (PR) in accordance with RECIST V1.1 definitions.

EFS is defined as the time from diagnosis to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST V1.1. Disease recurrence (local, regional, or distant) after surgery. Contralateral breast cancer. Second primary tumor. Death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer	NCT05843292	Triple-negative...	Taxane and Carb... Short-term Sint... Surgery	18 Years - 70 Years	Shanghai Jiao Tong University School of Medicine
Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer	NCT05843292	Triple-negative...	Taxane and Carb... Short-term Sint... Surgery	18 Years - 70 Years	Shanghai Jiao Tong University School of Medicine

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