Not Yet RecruitingPhase 3

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

China194 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 cardiovasc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pathologic Complete Response (pCR)

Timeframe: At the time of surgery, approximately 6-8 months after enrollment

Trial details

NCT IDNCT07269691

SponsorPengfei Qiu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Pengfei Qiu MD

+86-26215 qiupengfei2002@126.com

View on ClinicalTrials.gov More Breast Cancer Early Stage Breast Cancer (Stage 1-3) trials