AI takes on breast cancer: could a computer pick better treatment than standard care?
NCT ID NCT07528716
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests whether an artificial intelligence (AI) model can choose the best combination of targeted drugs for women with HER2-positive breast cancer before surgery. About 280 women with early or locally advanced breast cancer will be randomly assigned to either AI-guided therapy or standard therapy. The goal is to see if the AI approach leads to a higher rate of complete cancer disappearance at the time of surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- 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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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: * Female patients aged 18 to 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Histologically confirmed unilateral primary invasive breast cancer, staged as at least cT2 or cN1 (i.e., AJCC 8th edition stage II-III), and M0. * Pathologically confirmed HER2-positive breast cancer, defined as HER2 IHC 3+, or IHC 2+ with positive in situ hybridization (ISH). * At least one measurable lesion according to RECIST version 1.1. * Adequate major organ function, meeting all of the following criteria: Hematology criteria (without blood transfusion or hematopoietic growth factor support within 7 days before screening): hemoglobin (HB) \>= 90 g/L; absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L; platelet count (PLT) \>= 75 x 10\^9/L. * Biochemistry criteria: total bilirubin (TBIL) \<= 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 3 x ULN; serum creatinine (Cr) \<= 1.5 x ULN; endogenous creatinine clearance \> 50 mL/min (Cockcroft-Gault formula). * 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 msec; echocardiography: left ventricular ejection fraction (LVEF) \>= 55%. * Women of childbearing potential must use at least one medically accepted contraceptive method during study treatment and for at least 3 months after the last dose of study drug. * Subjects must voluntarily participate in the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up. Exclusion Criteria: * Bilateral breast cancer, inflammatory breast cancer, or clinically stage IV (metastatic) breast cancer. * Any prior systemic targeted therapy, chemotherapy, endocrine therapy, biologic therapy, radiotherapy, or immunotherapy for any reason. * Any of the following comorbidities, medical histories, or treatment histories: * Known or suspected interstitial pneumonitis; or moderate to severe pulmonary disease severely affecting respiratory function, such as severe asthma or severe chronic obstructive pulmonary disease (COPD). * Serious cardiovascular or cerebrovascular disease, including but not limited to New York Heart Association (NYHA) class II or higher heart failure (including class II), myocardial infarction or cerebrovascular accident (including cerebral ischemia or symptomatic cerebral infarction) within 3 months before first dosing, or persistent arrhythmia of grade \>= 2. * Severe systemic infection (e.g., requiring intravenous antibiotics, antifungal agents, or antiviral drugs according to clinical practice standards), or unexplained fever \> 38.5 degrees C during screening or before first dosing. * Clinically significant bleeding symptoms within 1 month before signing informed consent, or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or baseline fecal occult blood of ++ or above. * Known hypersensitivity or intolerance to the investigational medicinal products or their excipients. * Any other malignancy within the previous 5 years, except cured cervical carcinoma in situ or non-melanoma skin cancer. * Pregnancy or lactation, or refusal by women of childbearing potential to use appropriate contraception during the trial. * Participation in another clinical trial within 30 days before the first dose of study drug. * Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
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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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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, China
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