NCT07269691Not yet recruitingPhase 3
RaSOLVE: 125I Radioactive Seed Marking Effects on Pathological Complete Response Rate and Prognosis Post-Neoadjuvant Therapy in Early/Advanced Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Pengfei Qiu
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07269691
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 194
- From 1 Dec 2025 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 1 year.
- Prior exposure to anthracyclines, taxanes, or platinum agents.
- Vaccination with live attenuated vaccine within 28 days.
- Major surgery within 28 days (except diagnostic procedures).
- Treatment with systemic immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks.
Other illness
- 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.
- 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.
- Active HBV, HCV, or HIV infection.
- Severe infection within 4 weeks or systemic antibiotic-treated infection within 2 weeks.
- History of bone marrow or organ transplantation.
- Known allergy to study agents.
- Substance abuse or psychiatric conditions that may affect compliance.
- Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.
Lab values
- Coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN).
Other
- Peripheral neuropathy ≥ Grade 2.
- Participation in another clinical trial within 4 weeks.
- Pregnancy, breastfeeding, or planning pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Cancer Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.