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AI takes on breast cancer: could a computer pick better treatment than standard care?

NCT ID NCT07528716

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

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 to 75 years

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: * 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

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Other studies related to the condition(s) this trial covers.