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Gene test may spare breast cancer patients from unnecessary radiation
NCT ID NCT04069884
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing whether a genetic test called RecurIndex can identify breast cancer patients with cancer in their lymph nodes who can safely skip radiation to the lymph nodes. The goal is to reduce side effects like arm swelling and pain without increasing the risk of cancer coming back. The trial will enroll 540 patients and follow them for several years to compare outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- regional nodal irradiation (radiation therapy)
- What this could lead to
- If successful, this could allow many breast cancer patients to safely skip radiation to the lymph nodes, reducing side effects like arm swelling and pain.
- What could go wrong
- This is an early-stage validation study with 540 participants, so results may not apply to all patients. The genetic test might not accurately predict who needs radiation, potentially increasing recurrence risk.
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
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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
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About 540 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2019
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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)Three subtypes are allowed (Lumina A, Lumina B/HER2 negative, Lumina B/HER2 positive) , namely ER positive (ER ≥ 1%), HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH) or ER positive (ER ≥ 1%), HER2 positive (3+ by IHC, or 2+ but positive 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 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. * No contralateral breast cancer must be confirmed by molybdenum target and/or MRI within 12 months before randomization of radiotherapy. * At least 4 courses of adjuvant chemotherapy with anthracycline or taxane should be completed after surgery. If patients with HR positive, HER2 negative tumor underwent Multigene Assays, with low risk scores, omitting chemotherapy is permitted. * Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy. * The patient must have sufficient primary fresh frozen specimens or post-paraffin tissue sections for RecurIndex testing. * 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RECRUITINGGuangzhou, Guangdong, 510120, China
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