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No knife needed? new trial tests if chemo and radiation alone can cure breast cancer

NCT ID NCT06498154

Disease control Sponsor: Tianjin Medical University Cancer Institute and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 trial is testing whether women with certain aggressive breast cancers (triple negative or HER2-positive) can safely avoid breast surgery if their tumors disappear completely after a combination of chemotherapy and radiation. The study will enroll 200 women and follow them for 5 years to see if the cancer stays away. If it works, it could spare many patients from surgery and its recovery time.

What this could mean

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

Active substance
chemotherapy (TCb regimen with or without immunotherapy for triple negative; TCb plus trastuzumab and pertuzumab for HER2+) and radiotherapy (whole-breast irradiation plus boost)
What this could lead to
If successful, this could show that some breast cancer patients can avoid surgery entirely after strong chemo and radiation, reducing treatment burden.
What could go wrong
This is a phase 2 trial with only 200 people, so results are preliminary. There is a risk that cancer may return without surgery, and the combination of chemo and radiation may cause more side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Started

Jul 2024

Expected to finish

Jun 2032

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 initial treatment patients aged ≥ 18 years and ≤ 70 years old * ECOG score 0-1 * Clinical T1-2N0 HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive) or triple negative invasive breast cancer * Left ventricular ejection fraction (LVEF) ≥ 50% * 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females\<470ms * The functional level of the main organs must meet the following requirements: blood routine: ANC ≥ 1.5 × 109/L# PLT≥90 × 109/L# Hb≥90 g/L#Blood biochemistry: TBIL ≤ 2.5 × ULN# ALT and AST ≤ 2.5 × ULN# BUN and Cr ≤ 1.5 × ULN# * For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment * Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up. Exclusion Criteria: * Inflammatory breast cancer * Metastatic tumor * Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol. * Active infections that require systemic treatment * Has used any medication in this study within 14 days prior to enrollment * Major surgery (excluding biopsy) performed within 14 days before enrollment

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer

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

  • Tianjin medical university cancer institute and hospital

    RECRUITING

    Tianjin, China

More trials for these conditions

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