New scan technique aims to personalize breast cancer therapy
NCT ID NCT07419867
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether special PET/MRI scans can predict how well breast cancer treatments work. 300 women will get scans before and after two cycles of therapy. The goal is to find which scan patterns match good or poor responses, helping doctors choose the right treatment for each patient in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PET/MRI scans with specific tracers (18F-FDG, HER2, FAPI)
- What this could lead to
- If successful, this could help doctors predict which breast cancer treatments work best for each patient, personalizing care.
- What could go wrong
- This is an early, exploratory phase II trial. It is designed to gather information, not to prove a treatment works. The results may not lead to immediate changes in 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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2032
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 70 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: 1. Female patients aged 18 to 70 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 3. Histologically confirmed invasive breast cancer. 4. Known ER, PR and HER2 status. 5. At least one measurable lesion according to RECIST 1.1. 6. Adequate organ function, meeting all of the following: * Hemoglobin (Hb)≥90 g/L; * Absolute neutrophil count (ANC)≥1.5×10\^9/L; * Platelet count (PLT)≥100×10\^9/L; * Total bilirubin (TBIL)≤1.5×the upper limit of normal (ULN); * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN; * Alkaline phosphatase (ALP)≤2.5×ULN; * Serum creatinine (Cr)≤1.5×ULN; * Prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN, and international normalized ratio (INR)≤1.5×ULN (in patients not receiving anticoagulation). 7. Left ventricular ejection fraction (LVEF)≥55% at baseline as measured by echocardiography or multi-gated acquisition (MUGA) scan. 8. Women of childbearing potential must have a negative serum pregnancy test. Such patients must use a medically acceptable method of contraception during study treatment and for at least 6 months after the last dose of the study drug(s). 9. The subject voluntarily agrees to participate, signs the informed consent form, has good compliance, and is willing to adhere to follow-up. Exclusion Criteria: 1. Any other malignancy within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer. 2. Diabetics or those allergic to radionuclides who are not suitable for 18F-FDG PET/MR examination. 3. Serious cardiovascular or cerebrovascular disease within 6 months prior to randomization, including but not limited to congestive heart failure, unstable angina, severe arrhythmias uncontrolled by medication, severe conduction abnormalities or clinically significant valvular disease, uncontrolled severe hypertension, myocardial infarction, or cerebrovascular accident. 4. Any serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). 5. Major surgery within 4 weeks prior to randomization without full recovery, or an anticipated need for major surgery during study treatment. 6. Known active liver disease, including but not limited to active hepatitis B (defined as HBsAg positive with HBV-DNA≥1000 IU/mL), hepatitis C (defined as HCV-Ab positive with HCV-RNA above the assay's lower limit of quantification), or autoimmune liver disease. 7. Severe and uncontrolled infection or known HIV infection. 8. Active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment) or fungal infection. 9. Pregnant or breastfeeding. 10. Known allergy to the study drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies. 11. Known abuse of psychotropic substances, alcoholism, or drug abuse. 12. Known, definite neurological or psychiatric disorders associated with poor compliance, including but not limited to epilepsy or dementia. 13. Any other serious physical or mental illness or laboratory abnormality that may increase the risk of study participation or interfere with study treatment and outcomes, or any other condition that, in the investigator's judgment, makes the patient unsuitable for this study. 14. Receiving radiotherapy (except for palliative reasons), chemotherapy and immunotherapy within 3 weeks before treatment, excluding bisphosphonates (can be used for bone metastasis).
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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
Shanghai, Shanghai Municipality, 200032, China
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