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

NCT07827079 | Completed Phase 2 DMC

• 1 other identifier: Ratification NO: 2024（82-02）
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemeotherapy; Breast Cancer (Triple Negative Breast Cancer (TNBC))

Keywords

Triple Negative Breast Cancer; chemeotherapy

Outcome Measures

Primary Outcomes (1)

• pCR rate

  pathological complete response (pCR)

  Periprocedural（up to after-surgery two weeks）

Secondary Outcomes (4)

• TRAE

  Baseline;The third day after each chemotherapy cycle; Perioperative; Periprocedural

• results of whole-exome sequencing (WES) and transcriptome sequencing

  Periprocedural(through study completion, an average of 1 year)

• EFS

  through study completion, an average of 1 year

• OS

  through study completion, an average of 1 year

Study Arms (1)

training group

EXPERIMENTAL

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

Interventions

Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab DRUG

Paticients received 6 cycles of tislelizumab concomitant with the TAC regimen, followed by surgery. TAC regimen includes: nab paclitaxel, anthracyclines，cyclophosphamide.

training group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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):
• Hemoglobin (HB) ≥ 9 g/dL;
• Absolute neutrophil count (ANC) ≥ 1.5 × 10/L;
• Platelet (PLT) count ≥ 100 × 10/L;
• Biochemical tests:
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); or total bilirubin higher than ULN with direct bilirubin ≤ ULN;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
• 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).

You may not qualify if:

• \) 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.
• \) Receipt of chemotherapy, radiotherapy, or targeted therapy within 12 months prior to enrollment.
• \) Previous participation in clinical studies involving immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
• \) Known hypersensitivity to the active ingredients or excipients of tislelizumab, albumin-bound paclitaxel, cyclophosphamide, or anthracycline agents.
• \) 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.
• \) Presence of any severe and/or uncontrolled underlying diseases, including:
• Uncontrolled hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg;
• 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);
• Active or uncontrolled severe infections;
• Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment;
• Renal failure requiring hemodialysis or peritoneal dialysis;
• A history of immune deficiency diseases, including HIV positivity, other acquired or congenital immune disorders, or a history of organ transplantation;
• Poorly controlled diabetes with fasting blood glucose (FBG) \> 10 mmol/L;
• Urinalysis showing urine protein ≥ ++, with a confirmed 24-hour urinary protein quantification \> 1.0 g;
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Army medical Cnter

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Anthracyclines; tislelizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: group1: 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).

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: July 1, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

CN (1)