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Radioactive seeds aim to boost Chemo's punch against breast cancer

NCT ID NCT07269691

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether placing tiny radioactive seeds in breast tumors before chemotherapy can help eliminate cancer more completely. About 194 women with early or locally advanced breast cancer will either get standard chemo alone or chemo plus seed placement. The goal is to see if the seeds increase the rate of complete cancer disappearance and improve long-term survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iodine-125 radioactive seed
What this could lead to
If it works, this could improve the chance of eliminating all cancer before surgery and lead to better long-term survival for women with early or locally advanced breast cancer.
What could go wrong
This is a relatively small phase 3 trial, and the benefit of radioactive seeds is unproven. There is a risk of seed migration or local side effects, and the approach may not improve outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 194 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shandong Cancer Hospital affiliated to Shandong First Medical University

    Jinan, Shandong, 250117, China

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Other studies related to the condition(s) this trial covers.