Breast Cancer (Triple Negative Breast Cancer (TNBC))Phase 2NCT07827079
A Study of Tislelizumab Combined With TAC Regimen as Neoadjuvant Therapy for TNBC
A Phase 2 study testing Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)) and Chemeotherapy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer (Triple Negative Breast Cancer (TNBC)), Chemeotherapy
- What is being tested?
- Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- Hemoglobin (HB) ≥ 9 g/dL;
- Absolute neutrophil count (ANC) ≥ 1.5 × 10/L;
- Platelet (PLT) count ≥ 100 × 10/L;
- Biochemical tests:
Show all 9Show fewer
- 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).
Who cannot join
- 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:
Show all 21Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab
- Keywords
- Triple Negative Breast Cancer, chemeotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxel/Carboplatin, anthracyclines,TislelizumabDrug
Paticients received 6 cycles of tislelizumab concomitant with the TAC regimen, followed by surgery. TAC regimen includes: nab paclitaxel, anthracyclines，cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pathological complete response (pCR)
Measured: Periprocedural（up to after-surgery two weeks）
Secondary outcomes (4)
TRAE
Treatment-Related Adverse Event
Measured: 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.
Measured: Periprocedural(through study completion, an average of 1 year)
EFS
Progress-free survival
Measured: through study completion, an average of 1 year
OS
Overall survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Oct 2024
- Primary completion1 May 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Triple Negative Breast Cancer (TNBC))Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827079
- Sponsor's protocol ID
- Ratification NO: 2024（82-02）
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Phase II Study of Tislelizumab Combined With TAC Regimen as Neoadjuvant Therapy for TNBC
- ClinicalTrials.gov ID
- NCT07827079
- Acronym / sponsor ID
- Ratification NO: 2024（82-02）
- Keywords
- Triple Negative Breast Cancer, chemeotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Drug: Nab paclitaxel/Carboplatin, anthracyclines,TislelizumabParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Hemoglobin (HB) ≥ 9 g/dL;
- Absolute neutrophil count (ANC) ≥ 1.5 × 10/L;
- Platelet (PLT) count ≥ 100 × 10/L;
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); or total bilirubin higher than ULN with direct bilirubin ≤ ULN;
Key exclusion criteria (21 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab paclitaxel/Carboplatin, anthracyclines,TislelizumabPaticients received 6 cycles of tislelizumab concomitant with the TAC regimen, followed by surgery. TAC regimen includes: nab paclitaxel, anthracyclines，cyclophosphamide. | Drug | training group |
Primary outcome
pCR rate
Time frame: Periprocedural（up to after-surgery two weeks）
pathological complete response (pCR)
4 secondary outcomes
TRAE
Time frame: Baseline;The third day after each chemotherapy cycle; Perioperative; Periprocedural
results of whole-exome sequencing (WES) and transcriptome sequencing
Time frame: Periprocedural(through study completion, an average of 1 year)
EFS
Time frame: through study completion, an average of 1 year
OS
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer (Triple Negative Breast Cancer (TNBC))
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab paclitaxel/Carboplatin, anthracyclines,Tislelizumab in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)) and Chemeotherapy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: Periprocedural（up to after-surgery two weeks）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.