Breast CancerNCT07179744
Regional Radiotherapy Omission in Low-Risk Node Positive Breast Cancer
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether certain patients can safely omit regional lymph node radiotherapy. These women must have hormone-sensitive, Her2-negative tumors, have 1-3 positive axillary nodes and have RecurIndex low-risk. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omission of Regional Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 635 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2022to 5 Jul 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pT1-2N1M0 breast cancer
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yuting Tan, 8615913198466, tanyt3@mail.sysu.edu.cn
Xiaobo Huang, 8613556080080, huangxb@mail.sysu.edu.cn
About this study
Official title: A Multicenter, Prospective, Observational Study of Regional Radiotherapy Omission in Node Positive Patients With RecurIndex Low-risk Breast Cancer
The purpose of this study is to determine whether certain patients can safely omit regional lymph node radiotherapy. These women must have hormone-sensitive, Her2-negative tumors, have 1-3 positive axillary nodes and have RecurIndex low-risk.
- Conditions
- Breast Cancer
- Being tested
- Omission of Regional Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of Regional RadiotherapyProcedure or surgery
Omission of Regional Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Node Positive Breast Carcinoma | Omission of Regional Radiotherapy Receives: Procedure: Omission of Regional Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local-regional recurrence rate
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Measured: 5 years
Secondary outcomes (8)
Any first recurrence (AFR)
defined as any recurrence of ipsilateral chest, breast, regional lymph node recurrence, or distant metastases by Imaging or pathology
Measured: 5 years
Local-regional recurrence free survival (LRFS)
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Measured: 5 years
Recurrence free survival (RFS)
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Measured: 5 years
Disease free survival (DFS)
defined as time between randomization and the time of disease recur or death occur
Measured: 5 years
Beast cancer specific mortality (BCSM)
defined as time between randomization and the time of death occur specific due to breast cancer
Measured: 5 years
Overall Survival (OS)
defined as time between randomization and the time of death occurred
Measured: 5 years
Patient life quality measurement
At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cancer-30 (C30)
Measured: 5 years
Patient life quality measurement
At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Breast-23 (BR23)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start6 Jul 2022
- Primary completion6 Jul 2027 (estimated)
- Study completion5 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 635 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179744
- Sponsor's protocol ID
- REOM
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study of Regional Radiotherapy Omission in Node Positive Patients With RecurIndex Low-risk Breast Cancer
- ClinicalTrials.gov ID
- NCT07179744
- Acronym / sponsor ID
- REOM
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 635 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 5 Jul 2032 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether certain patients can safely omit regional lymph node radiotherapy. These women must have hormone-sensitive, Her2-negative tumors, have 1-3 positive axillary nodes and have RecurIndex low-risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Node Positive Breast Carcinoma | – | Procedure: Omission of Regional RadiotherapyOmission of Regional Radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pT1-2N1M0 breast cancer
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omission of Regional RadiotherapyOmission of Regional Radiotherapy | Procedure or surgery | Node Positive Breast Carcinoma |
Primary outcome
Local-regional recurrence rate
Time frame: 5 years
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
8 secondary outcomes
Any first recurrence (AFR)
Time frame: 5 years
Local-regional recurrence free survival (LRFS)
Time frame: 5 years
Recurrence free survival (RFS)
Time frame: 5 years
Disease free survival (DFS)
Time frame: 5 years
Beast cancer specific mortality (BCSM)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
Patient life quality measurement
Time frame: 5 years
Patient life quality measurement
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuting Tan (8615913198466, tanyt3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local-regional recurrence rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.