This study is an open-label, controlled, multicenter phase III clinical trial designed to evaluate whether the use of iodine-125 radioactive seed markers can improve treatment response for patients with early or locally advanced breast cancer undergoing neoadjuvant therapy.
Neoadjuvant therapy is widely used for breast cancer to shrink tumors, increase the chances of breast-conserving surgery, and help determine the most effective postoperative treatments. Achieving a pathological complete response (pCR) after neoadjuvant therapy is strongly associated with better long-term outcomes.
In this study, qualified participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group.
Experimental group: Patients will receive placement of iodine-125 seed markers in the primary breast tumor and biopsy-proven positive axillary lymph nodes before starting neoadjuvant therapy.
Control group: Patients will undergo standard neoadjuvant therapy without seed placement.
All participants will then complete neoadjuvant therapy followed by surgery. Pathological evaluation will determine whether the cancer has completely disappeared. Long-term outcomes, including invasive disease-free survival, will be followed for at least five years.
The goal of this study is to determine whether radioactive seed marking can increase the rate of pathological complete response and improve prognosis in patients receiving neoadjuvant therapy for breast cancer. The study will also explore whether iodine-125 seeds may activate immune responses that contribute to treatment effectiveness.
Female patients aged 18 to 70 years.
ECOG performance status 0-1.
Pathologically confirmed, previously untreated, unilateral primary invasive breast cancer.
Clinical stage cT1cN1-2M0 or cT2-3N0-2M0 (AJCC 8th edition).
Bilateral breast cancer or history of DCIS, LCIS, invasive breast cancer, or metastatic breast cancer.
Any malignancy diagnosed within the past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer.
Prior systemic chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 1 year.
Prior exposure to anthracyclines, taxanes, or platinum agents.
Parallel
Iodine-125 Radioactive Seed Marking
DeviceUltrasound-guided implantation of iodine-125 radioactive seeds (0.1-0.3 mCi) into the primary breast tumor and biopsy-confirmed positive axillary lymph nodes prior to the first cycle of neoadjuvant therapy. Seed position will be verified during treatment using ultrasound, mammography, and MRI. Arm(s) Applied to：
Standard Neoadjuvant Therapy
DrugSystemic neoadjuvant therapy based on breast cancer subtype and clinical guidelines, which may include chemotherapy, targeted therapy, immunotherapy, or endocrine therapy as assessed by investigators. All participants in both arms will receive neoadjuvant therapy followed by surgery.
Pathologic Complete Response (pCR)
Pathologic complete response (pCR) is defined as no residual invasive carcinoma in both the resected breast tissue and ipsilateral regional lymph nodes following completion of neoadjuvant therapy and surgery (ypT0/is, ypN0). Residual ductal carcinoma in situ (DCIS) may be present. This definition is fully consistent with the study protocol.
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Pengfei Qiu
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
