Breast NeoplasmNCT03269981
Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer
A study testing Whole breast irradiation and Whole breast and nodal irradiation in people with Breast Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Whole breast irradiation and Whole breast and nodal irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 827 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2017to 30 Dec 2029
- Phase
- Interventional
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven invasive carcinoma of the breast.
- One to three positive axillary lymph nodes (pN1) proven in pathologic specimen.
- Prior breast-conserving surgery and post-operative adjuvant chemotherapy including taxane.
- Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor.
- Administering anti-HER2 therapy in cases with HER2-positive tumor.
Who cannot join
- Metastases in supraclavicular or internal mammary lymph nodes.
- Metastases in distant organs.
- Neoadjuvant chemotherapy or hormone therapy before surgery.
- Not receiving adjuvant anthracycline and taxane.
- Bilateral breast cancer
- Previous history of radiotherapy of the ipsilateral breast or supraclavicular lymph nodes.
- Prior history of other types of cancer, except thyroid cancer, carcinoma in situ of the cervix, or skin cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Prospective Randomized Study of Elective Regional Lymph Node Irradiation in Pathologic N1 Breast Cancer Patients Treated With Breast Conserving Surgery
This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).
Read the detailed description
Objective:
- Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast cancer patients who received AT-based chemotherapy.
- Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor.
- Compare the treatment-related toxicities between the WBI and WB+RNI.
- Compare the patient's quality of life between the WBI and WB+RNI.
Outline: This is a a randomized, multi-center, phase III study. Patients are stratified according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy [SLN] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive WB+RNI.
- Arm II: Patients receive WBI alone.
Arm circumference and quality of life (EORTC QLQ-C30 \& EORTC QLQ-BR23) are assessed within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 months after completion of radiotherapy, and then annually thereafter for five years.
Patients are followed at 3 months after completion of radiotherapy and annually thereafter for seven years.
- Conditions
- Breast Neoplasm
- Being tested
- Whole breast irradiation, Whole breast and nodal irradiation
- Keywords
- Adjuvant radiotherapy, Lymphatic irradiation, Taxane, Anthracycline, Prospective study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole breast irradiationRadiation
Radiotherapy to the whole breast alone.
Whole breast and nodal irradiationRadiation
Radiotherapy to the whole breast and regional lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Whole breast irradiation | Experimental | Post-lumpectomy radiotherapy to the whole breast alone. Receives: Radiation: Whole breast irradiation |
| Whole breast and nodal irradiation | Active comparator | Post-lumpectomy radiotherapy to the whole breast and regional lymph node. Receives: Radiation: Whole breast and nodal irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival
Measured: 7 years
Secondary outcomes (4)
Disease-free survival according to molecular subtype
Disease-free survival according to molecular subtype
Measured: 5 years
Treatment-related toxicity
acute and chronic toxicities
Measured: 5 years
European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement
1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Measured: 5 years
EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement
1 (Not at all) to 4 (Very much). A higher score means more severe symptoms.
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 posted1 Sep 2017
- Study start1 Apr 2017
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Radiation Oncology Group, Ministry of Health, Republic of Korea
- Responsible party
- Sponsor
- Investigators
- Won Park, MD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269981
- Sponsor's protocol ID
- SMC 2017-01-085-001
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2017
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim N, Park W, Kim H, Cho WK, Ahn SJ, Kim MY, Park SH, Lee IJ, Ha I, Kim JH, Kim TH, Lee KC, Lee HS, Kim TG, Shin KH, Lee JH, Jung J, Cho O, Kim YB, Kim ES, Jo IY, Koo T, Kim K, Park HJ, Shin YJ, Ha B, Kwon J, Lee JH, Moon S. Patient-Reported Outcomes Between Whole-Breast Plus Regional Irradiation and Whole-Breast Irradiation Only in pN1 Breast Cancer After Breast-Conserving Surgery and Taxane-Based Chemotherapy: A Randomized Phase 3 Clinical Trial (KROG 17-01). Int J Radiat Oncol Biol Phys. 2025 Feb 1;121(2):341-351. doi: 10.1016/j.ijrobp.2024.09.017. Epub 2024 Sep 24.
PubMed 39326505
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Prospective Randomized Study of Elective Regional Lymph Node Irradiation in Pathologic N1 Breast Cancer Patients Treated With Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT03269981
- Acronym / sponsor ID
- SMC 2017-01-085-001
- Conditions
- Breast Neoplasm
- Keywords
- Adjuvant radiotherapy, Lymphatic irradiation, Taxane, Anthracycline, Prospective study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 827 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korean Radiation Oncology Group, Ministry of Health, Republic of Korea
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 1 Sep 2017 (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.
This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).
Detailed description
Objective:
- Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast cancer patients who received AT-based chemotherapy.
- Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor.
- Compare the treatment-related toxicities between the WBI and WB+RNI.
- Compare the patient's quality of life between the WBI and WB+RNI.
Outline: This is a a randomized, multi-center, phase III study. Patients are stratified according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy [SLN] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive WB+RNI.
- Arm II: Patients receive WBI alone.
Arm circumference and quality of life (EORTC QLQ-C30 \& EORTC QLQ-BR23) are assessed within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 months after completion of radiotherapy, and then annually thereafter for five years.
Patients are followed at 3 months after completion of radiotherapy and annually thereafter for seven years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole breast irradiation | Experimental | Radiation: Whole breast irradiationPost-lumpectomy radiotherapy to the whole breast alone. |
| Whole breast and nodal irradiation | Active comparator | Radiation: Whole breast and nodal irradiationPost-lumpectomy radiotherapy to the whole breast and regional lymph node. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven invasive carcinoma of the breast.
- One to three positive axillary lymph nodes (pN1) proven in pathologic specimen.
- Prior breast-conserving surgery and post-operative adjuvant chemotherapy including taxane.
- Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor.
- Administering anti-HER2 therapy in cases with HER2-positive tumor.
Key exclusion criteria (7 listed)
- Metastases in supraclavicular or internal mammary lymph nodes.
- Metastases in distant organs.
- Neoadjuvant chemotherapy or hormone therapy before surgery.
- Not receiving adjuvant anthracycline and taxane.
- Bilateral breast cancer
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 |
|---|---|---|
| Whole breast irradiationRadiotherapy to the whole breast alone. | Radiation | Whole breast irradiation |
| Whole breast and nodal irradiationRadiotherapy to the whole breast and regional lymph nodes. | Radiation | Whole breast and nodal irradiation |
Primary outcome
Disease-free survival
Time frame: 7 years
Disease-free survival
4 secondary outcomes
Disease-free survival according to molecular subtype
Time frame: 5 years
Treatment-related toxicity
Time frame: 5 years
European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement
Time frame: 5 years
EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) 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 27 Nov 2023.
- Derived from this study: PubMed 39326505Kim N, Park W, Kim H, Cho WK, Ahn SJ, Kim MY, Park SH, Lee IJ, Ha I, Kim JH, Kim TH, Lee KC, Lee HS, Kim TG, Shin KH, Lee JH, Jung J, Cho O, Kim YB, Kim ES, Jo IY, Koo T, Kim K, Park HJ, Shin YJ, Ha B, Kwon J, Lee JH, Moon S. Patient-Reported Outcomes Between Whole-Breast Plus Regional Irradiation and Whole-Breast Irradiation Only in pN1 Breast Cancer After Breast-Conserving Surgery and Taxane-Based Chemotherapy: A Randomized Phase 3 Clinical Trial (KROG 17-01). Int J Radiat Oncol Biol Phys. 2025 Feb 1;121(2):341-351. doi: 10.1016/j.ijrobp.2024.09.017. Epub 2024 Sep 24.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Won Park, MD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole breast irradiation and Whole breast and nodal irradiation in people with Breast Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2023. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269981, which also lists 1 linked publication.
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 27 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.