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

NCT07269691 | Not Yet Recruiting Phase 3

• 1 other identifier: SDZLEC2025-477-01
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Iodine-125 seed Radioactive seed marking Breast cancer Neoadjuvant therapy Pathological complete response

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Iodine-125 Seed Marking

EXPERIMENTAL

Participants in this arm will undergo ultrasound-guided implantation of Iodine-125 radioactive seeds (0.1-0.3 mCi) into the primary breast tumor and biopsy-confirmed metastatic axillary lymph nodes before starting neoadjuvant therapy. Seed position will be monitored every two cycles using ultrasound and confirmed preoperatively by mammography and MRI. After implantation, all participants will receive standard neoadjuvant therapy followed by surgery and pathological assessment according to study protocol.

Device: Iodine-125 Radioactive Seed Marking; Drug: Standard Neoadjuvant Therapy

No Seed Marking

ACTIVE COMPARATOR

Participants in this arm will receive standard neoadjuvant therapy without implantation of iodine-125 seeds. After neoadjuvant therapy is completed, participants will undergo surgery and pathological evaluation according to standard clinical practice.

Drug: Standard Neoadjuvant Therapy

Interventions

Standard Neoadjuvant Therapy DRUG

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.

Iodine-125 Seed Marking; No Seed Marking

Iodine-125 Radioactive Seed Marking DEVICE

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：

Iodine-125 Seed Marking

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pengfei Qiu: lead

Study Sites (1)

Shandong Cancer Hospital affiliated to Shandong First Medical University

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Pengfei Qiu MD

CONTACT

+86-26215; qiupengfei2002@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: Participants are randomized 1:1 to the iodine-125 seed marking group or the control group.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)