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Study tests skipping radiation for Low-Risk breast cancer patients

NCT ID NCT07179744

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study looks at whether women with a certain type of breast cancer (hormone-sensitive, HER2-negative, with 1-3 positive lymph nodes and a low RecurIndex score) can safely avoid radiation therapy to the lymph nodes. Researchers will follow 635 participants over time to see how many have their cancer come back. The goal is to find out if skipping this treatment is safe for low-risk patients.

What this could mean

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

What this could lead to
If successful, this could show that some women with low-risk breast cancer can avoid unnecessary radiation, reducing side effects and treatment burden.
What could go wrong
This is an observational study, not a treatment trial, so it won't prove a new therapy works. Results may not apply to all patients, and there is a risk of recurrence if radiation is omitted.

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.

Participants

About 635 people

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

Started

Jul 2022

Expected to finish

Jul 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.

Who is studied

pT1-2N1M0 breast cancer

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: * Age ≥ 18 years old, ≤ 70 years old. * Eastern Cooperative Oncology Group (ECOG) ≤ 2. * Postoperative pathology is clearly diagnosed as invasive breast cancer. Meet the clinical definition of low risk: ①Axillary lymph node micrometastasis (N1mic) or ②N1 patients who meet the following conditions at the same time, a)Age ≥ 40 years old, b)Vascular tumor thrombus (LVI) negative or allow few positive LVI (excluding extensive or massive LVI), c)ER positive (ER ≥ 1%) and HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH). * Postoperative pathological diagnosis of axillary lymph node status is any of the following: a. Sentinel lymph node biopsy or axillary lymph node dissection for micrometastasis (N1mic), b. Sentinel lymph node biopsy for 1-2 lymph node macrometastasis (N1sln), c. Sentinel lymph node biopsy + axillary lymph node dissection or simple axillary lymph node dissection for 1-3 lymph node metastasis (N1). * The patient must have sufficient primary fresh frozen specimens or post- paraffin tissue sections for RecurIndex testing. * Patients must have RecurIndex low risk obtained from testing of breast tumor tissue from a core biopsy or from the surgical specimen. * The primary tumor and breast undergo breast-conserving surgery or total resection ± breast reconstruction (autologous/prosthetic). * There must be adequate systemic examination (such as chest X-ray, B- ultrasound, CT, etc.) within 3 months before randomization of radiotherapy to confirm that there is no distant metastasis. * Preoperative or radiotherapy should be performed within 12 months of randomization and must have mammography and/or MRI to confirm that there is no contralateral breast cancer. * At least 4 courses of adjuvant chemotherapy with anthracycline or taxane should be completed after surgery. * Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy. * No previous history of malignant tumors, except for basal cell carcinoma of the skin. * Signed an informed consent form. Exclusion Criteria: * Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment. * Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy. * Patients who underwent total mastectomy and only sentinel lymph node biopsy. * Have a history of contralateral breast cancer. * History of chest radiotherapy. * combined with severe heart, lung, liver, kidney, hematopoietic, neurological diseases, and mental illness. * History of autoimmune diseases such as scleroderma or active lupus erythematosus. * pregnant and lactating patients.

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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

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    RECRUITING

    Guangzhou, Guangdong, 510120, China

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