Can immunotherapy plus chemo wipe out Triple-Negative breast cancer before surgery?

NCT ID NCT07827079

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether adding the immunotherapy drug tislelizumab to standard TAC chemotherapy helps shrink triple-negative breast cancer before surgery. The trial enrolls 36 women with newly diagnosed triple-negative breast cancer. Participants receive six cycles of tislelizumab plus nab paclitaxel, anthracyclines, and cyclophosphamide, then undergo surgery. The main goal is to see how many participants have no detectable cancer left in the breast and lymph nodes at surgery, and to track side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab, an immunotherapy drug, given with TAC chemotherapy (nab paclitaxel, anthracyclines, cyclophosphamide)
What this could lead to
If it works, this could point toward an immunotherapy-plus-chemotherapy combination that shrinks triple-negative breast cancer before surgery and lowers the chance of recurrence.
What could go wrong
This is a small, single-arm phase II study with 36 participants and no comparison group, so any benefit is hard to separate from chemotherapy alone. Immunotherapy can also cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Oct 2024

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Army medical Cnter

    Chongqing, Chongqing Municipality, China

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