Can a lighter treatment beat aggressive breast cancer?
NCT ID NCT07271992
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether a combination of two drugs—sacituzumab govitecan (a targeted chemotherapy) and tislelizumab (an immunotherapy)—can effectively treat early-stage triple-negative breast cancer with a less intense approach. The study will enroll 30 people and use specific biomarkers (Trop-2 and PD-L1) to identify who might benefit most. The main goal is to see how many patients have no cancer left after treatment, while also monitoring safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sacituzumab govitecan plus tislelizumab (a chemotherapy-antibody combo and an immunotherapy drug)
- What this could lead to
- If successful, this could show that some people with early triple-negative breast cancer can be treated effectively with a less intense combination, reducing side effects while still achieving a complete response.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The treatment still carries risks like immune-related side effects and chemotherapy toxicity, and it is not yet known if it works better than standard care.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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\. Age ≥ 18 years; 2. Histologically confirmed stage II or III primary invasive TNBC TNBC defined as: immunohistochemistry (IHC) ER and PR \<1%; HER2-negative, IHC 0 or 1+, IHC 2+, ISH-; 3. ECOG performance status score 0-1; 4. Provision of an acceptable tumor sample prior to randomization; 5. Bone marrow hematopoietic and organ function must meet study requirements; Without growth factor support or blood transfusion, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; Creatinine ≤ 1.5 × ULN; Urinalysis showing proteinuria \< 2+ or 24-hour urine protein \< 1 g; Coagulation function must be normal, defined as: International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN and/or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. If anticoagulant therapy is ongoing, PT must remain within the therapeutic range for the anticoagulant used. Serum amylase ≤ 1.5×ULN and serum lipase ≤ 1.5×ULN. Exclusion Criteria: * 1\. Evidence of severe/uncontrolled systemic disease, including active infections requiring intravenous therapy, severe chronic gastrointestinal disease associated with diarrhea, active bleeding disorders, severe cardiac or psychiatric disorders, or history of allogeneic organ transplantation; 2. History of other primary malignancies with known active disease within 3 years prior to randomization and low potential for recurrence (excluding adequately excised non-melanoma skin cancers and treated carcinoma in situ); 3. Active or documented history of autoimmune or inflammatory diseases; 4. Presence of distant metastases; 5. Active or uncontrolled hepatitis B or C infection, uncontrolled HIV infection, or active tuberculosis; 6. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, any clinically active interstitial lung disease, or immune-related pneumonitis induced by immunotherapy; 7. Any prior or concurrent surgery, radiotherapy, or systemic anticancer therapy for TNBC; 8. Prior exposure to the following treatments: Immunosuppressive drug therapy within 14 days before the first study intervention Live attenuated vaccines within 30 days before the first study intervention
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can Gene-Edited immune cells tame Hard-to-Treat cancers?
- Can a One-Time Anti-Inflammatory shot during surgery curb Triple-Negative breast Cancer's return?
- Triple-Drug cocktail aims to stall aggressive breast cancer
- Could a vaccine stop Triple-Negative breast cancer from coming back?
- Engineered immune cells take aim at Mesothelin-Positive tumors