ClinicalTrials.gg
CompletedNCT07827079Updated Sep 18, 2026

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

A Phase 2 interventional study of Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab in Breast Cancer (Triple Negative Breast Cancer (TNBC)) and Chemeotherapy, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Primary conditionTriple Negative Breast NeoplasmsRegistry: Breast NeoplasmsReclassifiedWhy we changed it
Registry
Breast Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Triple Negative Breast Neoplasms
Why
  1. The study's listed conditions name Triple Negative Breast Neoplasms, a narrower term within Breast Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Oct 2024, registered Aug 2026).
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

Keywords

  • Triple Negative Breast Cancer
  • chemeotherapy
03

In context

Triple Negative Breast Neoplasms Reclassified

1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 121 studies on the registry; 42 are open to participants now.

Compared within Triple Negative Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1) Signed written prior to the initiation of any study-related procedures; 2) Female patients aged 18 to 70 years; 3) Patients with 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 ()-negative, defined as IHC score of 0 or 1+, or IHC 2+ with negative fluorescence in situ hybridization (FISH) result; 4) Treatment-naive, non- (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) (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. (HB) ≥ 9 g/dL;
  2. (ANC) ≥ 1.5 × 10/L;
  3. (PLT) count ≥ 100 × 10/L;

Biochemical tests:

  1. Total (TBIL) ≤ 1.5 × (ULN); or total bilirubin higher than ULN with direct bilirubin ≤ ULN;
  2. (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
  3. Serum creatinine (Cr) ≤ 1.5 × ULN, or (CCr) ≥ 60 mL/min; 7) For women of , 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 status for at least 1 year, or history of surgical sterilization or hysterectomy; 8) All patients with fertility potential must adopt 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

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 , including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.

    4) Known to the active ingredients or 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 ≥ 480 ms), or Grade ≥ 2 congestive heart failure ( [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 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 ( 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 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.

Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • 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

Interventions

  • DrugNab paclitaxel/Carboplatin, anthracyclines,Tislelizumab

    Drug pages: Albumin-Bound 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.

06

What researchers measure

Primary outcomes

  1. pCR rate

    pathological complete response (pCR)

    Time frame: Periprocedural(up to after-surgery two weeks)

Secondary outcomes

  1. TRAE

    Treatment-Related Adverse Event

    Time frame: Baseline;The third day after each chemotherapy cycle; Perioperative; Periprocedural

  2. 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.

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

  3. EFS

    Progress-free survival

    Time frame: through study completion, an average of 1 year

  4. OS

    Overall survival

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Army medical Cnter
    Chongqing, Chongqing Municipality, China
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in May 2026, 19 months.

Of 220 non-industry phase 2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 99. This study's 19 months is below that.

Counting every sponsor, half of 255 studies reached it within 59 months; a quarter within 37 and three quarters within 94.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Sep 18, 2026
StartActual
Oct 1, 2024
Primary completionActual
May 1, 2026
CompletionActual
Jul 1, 2026
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07827079
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Oct 1, 2024
Primary completion
May 1, 2026
Completion
Jul 1, 2026
Last update
Sep 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Albumin-Bound Paclitaxel · Carboplatin · Anthracyclines · Tislelizumab

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