New drug duo aims to shrink aggressive breast cancer before surgery
NCT ID NCT07054242
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a combination of two drugs—sacituzumab tirumotecan and pembrolizumab—given before surgery to people with stage II or III triple-negative breast cancer. The goal is to see if the treatment can completely eliminate the cancer by the time of surgery. The study plans to enroll 52 participants who have not had prior treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sacituzumab tirumotecan (SKB264) and pembrolizumab
- What this could lead to
- If successful, this combination could become a new pre-surgery treatment option for triple-negative breast cancer, potentially improving the chance of eliminating the tumor before surgery.
- What could go wrong
- This is a small, early-phase trial with only 52 participants. The combination may cause side effects, and it is not yet known if it works better than current standard treatments.
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 52 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
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 to 75 years
- Sex
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Anyone
- 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. Histologically or cytologically confirmed stage II-III (T1cN1-2 or T2-4N0-2) triple-negative breast cancer (TNBC), defined as: * Immunohistochemistry (IHC) showing ER and PR \<1% * HER2-negative per 2028 ASCO-CAP guidelines (IHC 0/1+ or IHC 2+/ISH-) 2. Available tumor tissue sample for biomarker analysis. 3. At least one measurable lesion as per RECIST 1.1 criteria. 4. ECOG performance status 0-1. 5. Adequate organ function as evidenced by: * Absolute neutrophil count ≥1.5×10⁹/L (no G-CSF support within 14 days) * Platelets ≥100×10⁹/L (no transfusion within 14 days) * Hemoglobin \>9 g/dL (no transfusion/ESA within 14 days) * Total bilirubin ≤1.5×ULN * AST/ALT ≤1.5×ULN * Alkaline phosphatase ≤2.5×ULN * Serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault) * INR/PT ≤1.5×ULN * TSH within normal range (or normal FT3/FT4 if TSH abnormal) * Normal cardiac enzymes (isolated abnormalities allowed if clinically insignificant) 6. No prior anti-cancer therapy for current diagnosis. 7. For women of childbearing potential and men with WOCBP partners: agreement to use effective contraception from screening until 6 months post-treatment. 8. Willing and able to comply with study procedures and provide written informed consent. Exclusion Criteria: 1. LVEF \<50% by ECHO/MUGA or significant cardiac disease (NYHA Class III/IV). 2. Prior chemotherapy, targeted therapy, or radiotherapy for current breast cancer. 3. Previous treatment with immune checkpoint inhibitors (anti-PD-1/L1, anti-CTLA-4) or T-cell targeting therapies. 4. Prior Trop-2 directed therapy or topoisomerase I inhibitor treatment. 5. Other malignancies within 5 years (except adequately treated CIS of cervix, BCC, or cutaneous SCC). 6. Severe ocular surface disease (dry eye syndrome, meibomian gland dysfunction, or corneal disorders impairing healing). 7. Known hypersensitivity to study drug components. 8. History of immunodeficiency disorders or organ transplantation. 9. Current or history of: * Steroid-requiring interstitial lung disease/pneumoniti Unresolved ILD/pneumonitis on screening imaging Clinically significant pulmonary conditions including: * Recent pulmonary embolism (≤3 months) * Severe asthma/COPD/restrictive lung disease * Pleural effusion requiring intervention * Connective tissue disease with pulmonary involvement * Prior pneumonectomy 10. Active autoimmune disease requiring systemic treatment (past 2 years), except: * Hormone replacement therapy * Physiologic corticosteroid replacement 11. Active infection requiring systemic therapy within 14 days prior to initiation. 12. Uncontrolled comorbidities that may: * Compromise patient safety * Interfere with study completion 13. Any condition that in the investigator's judgment may: * Affect study drug evaluation * Compromise safety assessments * Interfere with data interpretation * Otherwise contraindicate participation
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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 places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Department of Breast Surgery, Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
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