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Life sciences · Interventional Study
ClinicalTrials.gov · October 15, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07875244). This is a study registration, not published results. Lead sponsor: Fudan University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1024 participants (ESTIMATED). Conditions: Breast Cancer, Neoadjuvant Therapy, Axilla; Breast. Interventions: DIAGNOSTIC_TEST: Serial MAMMI-BB PET Imaging. Primary outcome measures: Diagnostic Accuracy of Serial Changes in Breast Lesion SUVmax for Predicting Breast and Nodal Pathologic Complete Response , From baseline through definitive surgery, up to 8 months. 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.