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

NCT07269691 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-12-08

No results posted yet for this study

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 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.

Sponsors & Collaborators

  • Pengfei Qiu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269691 on ClinicalTrials.gov