MAMMI-BB PET for Monitoring Response to Neoadjuvant Therapy in Breast Cancer

NCT07875244 | Active Not Recruiting DMC

• 1 other identifier: 1912212-3
• Study Type: interventional
• Target: 1,024
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline through definitive surgery, up to 8 months

Secondary Outcomes (2)

• Progression-Free Survival

  5 years

• Disease-Free Survival

  5 years

Study Arms (1)

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.

Diagnostic Test: Serial MAMMI-BB PET Imaging

Interventions

Serial MAMMI-BB PET Imaging DIAGNOSTIC_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.

Serial MAMMI-BB PET Assessment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 15, 2026
• Study Start: June 27, 2019
• Primary Completion: October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)