A Study of Tislelizumab Combined With TAC Regimen as Neoadjuvant Therapy for TNBC

A Prospective, Open-Label, Single-Arm Phase II Study of Tislelizumab Combined With TAC Regimen as Neoadjuvant Therapy for TNBC

To assess the efficacy and safety of tislelizumab combined with TAC as neoadjuvant therapy for triple-negative breast cancer, and to preliminarily investigate its underlying molecular mechanisms.

Study Overview

• Status: Completed
• Conditions: Breast Cancer (Triple Negative Breast Cancer (TNBC)); Chemeotherapy
• Intervention / Treatment: Drug: Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab

Detailed Description

This study aimed to explore the efficacy and safety of tislelizumab combined with anthracycline- and taxane-based TAC regimen in neoadjuvant treatment for triple-negative breast cancer (TNBC). Whole-exome sequencing and transcriptome sequencing were performed on tumor tissue and peripheral blood samples collected from treated patients to further investigate the underlying molecular mechanisms of this combination therapy.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Army medical Cnter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) Signed written informed consent prior to the initiation of any study-related procedures; 2) Female patients aged 18 to 70 years; 3) Patients with pathologically confirmed primary invasive triple-negative breast cancer (TNBC). TNBC was defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative, defined as IHC score of 0 or 1+, or IHC 2+ with negative fluorescence in situ hybridization (FISH) result; 4) Treatment-naive, non-metastatic (M0) TNBC staged according to the 8th edition of the AJCC TNM staging system, with tumor stage of T1N0-2 or T2-4N0-2; 5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 6) Adequate major organ function within 7 days prior to treatment initiation, meeting the following criteria:

Routine blood tests (without blood transfusion within 14 days):

1. Hemoglobin (HB) ≥ 9 g/dL;
2. Absolute neutrophil count (ANC) ≥ 1.5 × 10/L;
3. Platelet (PLT) count ≥ 100 × 10/L;

Biochemical tests:

1. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); or total bilirubin higher than ULN with direct bilirubin ≤ ULN;
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;

3. Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (CCr) ≥ 60 mL/min; 7) For women of childbearing potential, a negative urine or serum pregnancy test within 3 days before the first administration of the study drug (Cycle 1 Day 1) was required. A serum pregnancy test was mandatory if the urine test result was inconclusive. Non-childbearing potential was defined as postmenopausal status for at least 1 year, or history of surgical sterilization or hysterectomy; 8) All patients with fertility potential must adopt contraceptive measures with an annual failure rate lower than 1% throughout the entire treatment period, until 120 days after the last administration of the study drug (or 180 days after the last chemotherapy administration).

   Exclusion Criteria:

   • 1) A history of other malignant tumors, or diagnosis of any other malignant disease within 2 years prior to enrollment. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin, and in situ carcinoma of the cervix or breast that has received radical curative treatment.

     2) Receipt of chemotherapy, radiotherapy, or targeted therapy within 12 months prior to enrollment.

     3) Previous participation in clinical studies involving immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.

     4) Known hypersensitivity to the active ingredients or excipients of tislelizumab, albumin-bound paclitaxel, cyclophosphamide, or anthracycline agents.

     5) Patients who are receiving or planning to receive human papillomavirus (HPV) vaccination during the study period, or those who completed their last HPV vaccination within less than 6 months before enrollment.

     6) Presence of any severe and/or uncontrolled underlying diseases, including:

     1. Uncontrolled hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg;
     2. Grade I or higher myocardial ischemia, myocardial infarction, arrhythmia (including QTc interval ≥ 480 ms), or Grade ≥ 2 congestive heart failure (New York Heart Association [NYHA] classification);
     3. Active or uncontrolled severe infections;
     4. Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment;
     5. Renal failure requiring hemodialysis or peritoneal dialysis;
     6. A history of immune deficiency diseases, including HIV positivity, other acquired or congenital immune disorders, or a history of organ transplantation;
     7. Poorly controlled diabetes with fasting blood glucose (FBG) > 10 mmol/L;
     8. Urinalysis showing urine protein ≥ ++, with a confirmed 24-hour urinary protein quantification > 1.0 g;

     9. A history of seizure disorders requiring clinical treatment; 7) Imaging evidence of tumor invasion into major blood vessels, or patients judged by the investigator to be at high risk of fatal massive hemorrhage caused by tumor invasion of vital blood vessels during the study period.

        8) A history of arterial or venous thromboembolic events within 6 months prior to enrollment, including cerebrovascular accidents (transient ischemic attack included), deep vein thrombosis, and pulmonary embolism.

        9) A history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment.

        10) Subjects with any signs or history of bleeding diathesis regardless of severity; subjects with any bleeding events of CTCAE Grade ≥ 3 within 4 weeks before the first study drug administration; or subjects with unhealed wounds, fractures, active gastroduodenal ulcers, ulcerative colitis, unresected tumors with active bleeding, or other conditions judged by the investigator to carry risks of gastrointestinal bleeding or perforation.

        11) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

        12) Participation in other clinical trials of anti-tumor drugs within 4 weeks prior to enrollment.

        13) Presence of any concomitant disease that may seriously endanger patient safety or interfere with study completion, as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: training group; Participants received six cycles of tislelizumab (200 mg, 21 days per cycle) concomitant with the TAC regimen, followed by definitive surgery. TAC regimen includes: nab paclitaxel (260 mg/m², once every 3 weeks), , anthracyclines，Cyclophosphamide (500 mg/m², once every 3 weeks).	Drug: Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab; Paticients received 6 cycles of tislelizumab concomitant with the TAC regimen, followed by surgery. TAC regimen includes: nab paclitaxel, anthracyclines，cyclophosphamide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	pathological complete response (pCR)	Periprocedural（up to after-surgery two weeks）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	through study completion, an average of 1 year
TRAE	Treatment-Related Adverse Event	Baseline;The third day after each chemotherapy cycle; Perioperative; Periprocedural
results of whole-exome sequencing (WES) and transcriptome sequencing	Whole-exome sequencing (WES) and transcriptome sequencing were performed on tumor tissue and peripheral blood samples to analyze sequencing results and further explore the molecular mechanisms.	Periprocedural(through study completion, an average of 1 year)
EFS	Progress-free survival	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): May 1, 2026
• Study Completion (Actual): July 1, 2026

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: September 13, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Triple Negative Breast Cancer; chemeotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Naphthacenes; Aminoglycosides; tislelizumab; Anthracyclines
• Other Study ID Numbers: Ratification NO: 2024（82-02）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No