Breast CancerMAMMI-PREDICTNCT07875244
MAMMI-BB PET for Monitoring Response to Neoadjuvant Therapy in Breast Cancer
A study testing Serial MAMMI-BB PET Imaging in people with Breast Cancer and Neoadjuvant Therapy, run by Fudan University at 1 site in China.
Trial summary
This prospective, single-center, open-label, single-arm study will evaluate MAMMI-BB positron emission tomography (PET) for monitoring response to neoadjuvant therapy in patients with breast cancer and baseline axillary lymph node involvement. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Therapy, Axilla; Breast
- What is being tested?
- Serial MAMMI-BB PET Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2019to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary invasive breast carcinoma confirmed by core needle biopsy of the breast lesion.
- Clinical stage cT1-4N0-3M0.
- Age 18 to 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Hepatic, renal, and cardiac function adequate to tolerate chemotherapy and targeted therapy, as applicable.
- Planned neoadjuvant chemotherapy with or without targeted therapy.
- Provision of informed consent before study participation.
Who cannot join
- Pregnancy or breastfeeding.
- Previous surgery or radiotherapy involving the ipsilateral axillary lymph nodes.
- Diabetes mellitus or allergy to the radiotracer rendering the patient unsuitable for 18F-FDG PET/CT examination.
- A history of, or concurrent, malignancy other than breast cancer, except non-melanoma skin cancer, carcinoma in situ of the cervix, or another malignancy considered cured with no evidence of recurrence for at least 5 years.
- Psychiatric illness or another condition affecting compliance with study requirements.
- Serious disease or medical conditions, including:- Congestive heart failure, unstable angina, myocardial infarction within 6 months before enrollment, hypertension considered uncontrolled by the investigator, or high-risk uncontrolled arrhythmia.
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- Significant neurological or psychiatric disorders that may impair understanding or provision of informed consent.
- Uncontrolled acute infection.
- An allergic predisposition or known or suspected allergy to any study medication.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Evaluating MAMMI-BB (Biplanar Breast) PET for Serial Monitoring of Response to Neoadjuvant Therapy in Breast Cancer
This prospective, single-center, open-label, single-arm study will evaluate MAMMI-BB positron emission tomography (PET) for monitoring response to neoadjuvant therapy in patients with breast cancer and baseline axillary lymph node involvement. Serial PET examinations will measure changes in maximum standardized uptake value (SUVmax) in breast lesions and axillary lymph nodes. These changes will be compared with surgical pathology to assess their ability to predict pathologic complete response separately in the breast and axilla and to identify the most informative assessment time point. Associations between PET parameters and long-term outcomes, including progression-free survival and disease-free survival, will also be explored.
- Conditions
- Breast Cancer, Neoadjuvant Therapy, Axilla; Breast
- Being tested
- Serial MAMMI-BB PET Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial MAMMI-BB PET ImagingDiagnostic test
Serial fluorine-18 fluorodeoxyglucose (18F-FDG) PET imaging of the breast and axilla using MAMMI-BB PET. Participants fast for at least 4 hours, undergo blood glucose and body weight measurements, and receive intravenous 18F-FDG. Imaging begins approximately 60 minutes after injection. Breast imaging is performed in the prone position, followed by axillary imaging in the standing position with the arm supported. SUVmax is measured separately in breast lesions and axillary lymph nodes at four planned assessment time points.
| Study group | Role | What they receive |
|---|---|---|
| Serial MAMMI-BB PET Assessment | Experimental | Breast cancer participants with or without baseline axillary lymph node involvement will undergo serial MAMMI-BB PET imaging before and during neoadjuvant therapy. PET parameters will be compared with surgical pathology to evaluate prediction of pathologic complete response in the breast and axilla. Receives: Diagnostic Test: Serial MAMMI-BB PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Serial Changes in Breast Lesion SUVmax for Predicting Breast and Nodal Pathologic Complete Response
The ability of relative changes in breast and axillary lesion SUVmax from baseline to the early, intermediate, and end-of-neoadjuvant-treatment assessments to predict breast pathologic complete response will be evaluated using postoperative histopathology as the reference standard. ROC analysis and estimates of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy with 95% confidence intervals will be used.
Measured: From baseline through definitive surgery, up to 8 months
Secondary outcomes (2)
Progression-Free Survival
Time from enrollment to first documented disease progression or death from any cause, whichever occurs first. Tumor progression will be assessed according to RECIST version 1.1 during neoadjuvant therapy and by documented recurrence during follow-up. The correlation between serial MAMMI-BB PET SUVmax parameters and progression-free survival will be explored using Cox proportional hazards models.
Measured: 5 years
Disease-Free Survival
Time from definitive surgery to first documented local, regional, or distant recurrence, or death from any cause, whichever occurs first. The correlation between serial MAMMI-BB PET SUVmax parameters and disease-free survival will be explored using Cox proportional hazards models.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start27 Jun 2019
- Primary completionOct 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,024 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875244
- Sponsor's protocol ID
- 1912212-3
- Acronym
- MAMMI-PREDICT
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No