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NCT07269691

PHASE3

RaSOLVE: 125I Radioactive Seed Marking Effects on Pathological Complete Response Rate and Prognosis Post-Neoadjuvant Therapy in Early/Advanced Breast Cancer

Sponsor: Pengfei Qiu

View on ClinicalTrials.gov

Summary

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.

Official title: RaSOLVE: An Open-Label, Controlled, Randomized, Multicenter Phase III Clinical Trial Assessing the Impact of Preoperative 125I Radioactive Seed Localization on Pathological Complete Response Rate (tpCR: ypT0/is ypN0) and Long-Term Prognosis (iDFS/OS) in Women With Early or Locally Advanced Newly Diagnosed Untreated Breast Cancer Following Neoadjuvant Therapy

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2025-12-01

Completion Date

2027-12-01

Last Updated

2025-12-08

Healthy Volunteers

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer

Interventions

DEVICE

Iodine-125 Radioactive Seed Marking

Ultrasound-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：

DRUG

Standard Neoadjuvant Therapy

Systemic 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.

Inclusion Criteria: * 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). * Adequate organ function within 7 days prior to randomization: * Hemoglobin ≥ 90 g/L * ANC ≥ 1.5×10⁹/L; Lymphocyte count ≥ 0.5×10⁹/L * Platelet count ≥ 100×10⁹/L * WBC 3.0-15×10⁹/L * ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; TBIL ≤ 1.5×ULN * Serum creatinine ≤ 1.5×ULN and creatinine clearance ≥ 60 mL/min * PT, APTT ≤ 1.5×ULN * Urine protein \< 2+ or 24-hour urine protein ≤ 1 g * LVEF ≥ 55% * QTcF \< 470 ms * Negative serum pregnancy test within 3 days prior to first treatment for women of childbearing potential and agreement to use effective contraception. * Willing and able to sign informed consent. Exclusion Criteria: * 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. * Primary or secondary immunodeficiency; uncontrolled autoimmune disease (except controlled hypothyroidism or type 1 diabetes). * Interstitial lung disease or severe chronic lung disease. * Clinically significant cardiovascular disease, including: * NYHA class ≥ III * Myocardial infarction or stroke within 3 months * Uncontrolled hypertension * Clinically significant arrhythmia or heart failure * Arterial/venous thrombosis within 3 months. * Vaccination with live attenuated vaccine within 28 days. * Active HBV, HCV, or HIV infection. * Major surgery within 28 days (except diagnostic procedures). * Severe infection within 4 weeks or systemic antibiotic-treated infection within 2 weeks. * History of bone marrow or organ transplantation. * Coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN). * Peripheral neuropathy ≥ Grade 2. * Treatment with systemic immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks. * Known allergy to study agents. * Participation in another clinical trial within 4 weeks. * Pregnancy, breastfeeding, or planning pregnancy. * Substance abuse or psychiatric conditions that may affect compliance. * Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.

Locations (1)

Shandong Cancer Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China