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Can less radiation be just as effective for some breast cancers?

NCT ID NCT07469267

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial is testing whether giving radiation only to the lower armpit lymph nodes works as well as giving radiation to a larger area of lymph nodes in breast cancer patients who have 1-2 positive sentinel nodes. The study plans to enroll 1608 women with early-stage breast cancer. The goal is to see if the smaller radiation field can prevent cancer from coming back while potentially causing fewer side effects.

What this could mean

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

Active substance
radiation therapy
What this could lead to
If successful, this could show that a smaller radiation field is just as effective as full regional radiation, reducing side effects for many breast cancer patients.
What could go wrong
This is an ongoing phase 3 trial, so results are not yet known. It is possible that the smaller radiation field may lead to higher recurrence rates, and the study only includes a specific group of patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,608 people

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

Started

Oct 2025

Expected to finish

Dec 2035

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 years and older

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: 1. Female ≥ 18 years of age; 2. Newly diagnosed primary invasive breast cancer; 3. Clinically stage T1-3N0M0; 4. Patients received surgery as first treatment,and have undergone breast conserving-surgery or mastectomy (with or without breast reconstruction) with negative margins; 5. Have one or two macrometastases (\>2 mm) at sentinel lymph node biopsy,and without further axillary lymph node dissection; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 7. Will receive endocrine therapy for at least 5 years for estrogen receptor (ER) and/or progesterone receptor (PR) positive patients; will receive anti-HER2 (human epidermal growth factor receptor 2) therapy for 1 year for HER2 positive patients; 8. Radiation therapy must begin no later than 12 weeks after the last dose of adjuvant chemotherapy or the last breast cancer surgery if no adjuvant chemotherapy; 9. Patients have adequate organ function; 10. Acquirement of informed consent. Exclusion Criteria: 1. Patients have received neoadjuvant systemic therapy; 2. Clinical stage T4 or IV (metastatic) breast cancer, or presence of regional metastases before surgery; 3. History of any prior ipsilateral or contralateral invasive breast cancer, history of other malignancies except for appropriately treated skin basal cell carcinoma and cervical carcinoma in situ; 4. History of previous radiotherapy towards the ipsilateral chest/lymph nodes. 5. The ipsilateral axillary lymph node dissection or other previous axillary surgery; 6. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, or psychiatric disease), inability to tolerate radiotherapy or systemic therapy if indicated; 7. Current pregnancy and/or lactation; 8. Inability or unwillingness to comply with protocol requirements.

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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

    15 sites. 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

  • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

    NOT_YET_RECRUITING

    Jinan, Shandong, China

  • Changde Hospital, Xiangya school of Medicine, Central South University (The first people's hospital of Changde city)

    NOT_YET_RECRUITING

    Changde, Hunan, China

  • Department of Chemoradiation Oncology, The Affiliated Lihuili Hospital of Ningbo University

    NOT_YET_RECRUITING

    Ningbo, Zhejiang, China

  • Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Department of Radiation and Medical Oncology, Affiliated Zhongshan Hospital of Dalian University

    NOT_YET_RECRUITING

    Dalian, Liaoning, China

  • Department of Radiation and Medical Oncology,Zhongnan Hospital of Wuhan University

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Harbin Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, China

  • Hunan cancer hospital/The affiliated cancer hospital of xiangya school of medicine,Central South university

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Oncology Department, Guizhou Provincial People's Hospital

    NOT_YET_RECRUITING

    Guiyang, Guizhou, China

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • The Fourth Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Zhejiang University

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • Tianjin Medical University Cancer Institute and Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, China

  • Zhejiang Cancer Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

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