Breast NeoplasmsPhase 3IMN-NeoNCT07915739
Internal Mammary Node Irradiation After Neoadjuvant Systemic Therapy for Breast Cancer
A Phase 3 study testing Locoregional Radiotherapy With Internal Mammary Node Irradiation and Locoregional Radiotherapy Without Internal Mammary Node Irradiation in people with Breast Neoplasms, run by Mahidol University at 9 sites in Thailand.
Trial summary
This multicenter randomized controlled trial evaluates whether internal mammary node irradiation (IMNI) improves oncologic outcomes in patients with breast cancer who have residual pathologically positive lymph nodes after neoadjuvant systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Locoregional Radiotherapy With Internal Mammary Node Irradiation and Locoregional Radiotherapy Without Internal Mammary Node Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,760 participants
- Where
- 9 sitesThailand
- Study dates
- 1 Jul 2027to 1 Jul 2036
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer with pathologically proven lymph node positivity after neoadjuvant systemic therapy.
- Received neoadjuvant chemotherapy and/or targeted therapy and/or immunotherapy before surgery.
- Underwent either breast-conserving surgery or mastectomy with lymph node evaluation and is planned to receive adjuvant locoregional radiotherapy.
- Planned treatment with three-dimensional conformal radiotherapy (3D-CRT) or a more advanced radiotherapy technique.
- Female ≥ 18 years
Who cannot join
- Clinical or radiologic evidence of internal mammary lymph node involvement of any size.
- Inflammatory breast cancer.
- Bilateral breast cancer.
- Multiple primary malignancies, except basal cell carcinoma and premalignant gynecologic lesions including CIN, HSIL, LSIL, VIN, and VAIN.
- Prior chest irradiation.
- Disease progression before radiotherapy.
- Metastatic disease (M1) according to the AJCC 8th edition.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Thailand9 sites
Siriraj Hospital
Bangkok, Bangkok Noi, 10700
Tanun Jitwatcharakomol, MD, +66909623000, tanun.jit@mahidol.ac.th
Tanun Jitwatcharakomol, MD
Chulabhorn Hospital
Bangkok
Ruja Vijitvejpaisarn, MD, +662-576-6021, ruja.sri@cra.ac.th
Areeya Tinsurawattana, MD
Chonburi Cancer Hospital
Chon Buri
Sirentra Wanglikitkoon, MD, +66 38 455 456, sirentra@hotmail.com
Vibharam Amata Nakorn Cancer Hospital
Chon Buri
Nuttawut Jeebjong, MD, +66663266150, nuttawutjee@gmail.com
Lop Buri Cancer Hospital
Lopburi
Peerawut Nathakankitkul, MD, +6691-549-6198, Peerawut_9@hotmail.com
Synphaet Hospital Nakhon Pathom
Nakhon Pathom
Nawaporn Pongsak, MD, +66909941192, nwp.pongsak@gmail.com
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat
Yatra Bunchuay, MD, +6689-870-8701, Kawfang124@gmail.com
Ratchaburi Hospital
Ratchaburi
Siriphan Leangcharoensap, MD, +66844240467, yuiysl93@gmail.com
Metropolitan Hospital Tha Chalom, Samut Sakhon Hospital
Samut Sakhon
Ukrit Choochinprakarn, MD, +66829592669, ukrit.cho@gmail.com
About this study
Official title: Internal Mammary Node Irradiation Versus Omission of Internal Mammary Node Irradiation in Breast Cancer Treated With Neoadjuvant Systemic Therapy: A Phase III Multicenter Randomized Trial
This multicenter randomized controlled trial evaluates whether internal mammary node irradiation (IMNI) improves oncologic outcomes in patients with breast cancer who have residual pathologically positive lymph nodes after neoadjuvant systemic therapy.
Eligible participants will be randomly assigned in a 1:1 ratio to receive locoregional radiotherapy either with or without irradiation of the internal mammary lymph nodes. The primary outcome is disease-free survival. Secondary outcomes include overall survival, breast cancer mortality, locoregional recurrence-free survival, distant metastasis-free survival, and treatment-related toxicity, particularly cardiac and pulmonary toxicity.
A total of 1,760 participants are planned to be enrolled across multiple centers in Thailand.
Read the detailed description
Regional nodal irradiation is an established component of adjuvant radiotherapy for selected patients with node-positive breast cancer. However, the additional benefit of internal mammary node irradiation (IMNI) remains uncertain, particularly in patients receiving contemporary neoadjuvant systemic therapy. Although previous randomized trials have demonstrated potential oncologic benefits of regional nodal irradiation incorporating IMNI, most were conducted in patients undergoing upfront surgery, before the widespread use of modern systemic treatments. Consequently, the benefit-risk balance of IMNI in patients with residual nodal disease after neoadjuvant systemic therapy remains unclear.
IMN-Neo is a phase III, multicenter, randomized, open-label superiority trial designed to evaluate whether the addition of IMNI to standard locoregional radiotherapy improves oncologic outcomes in patients with residual pathologically positive axillary lymph nodes following neoadjuvant systemic therapy.
Participants will be randomized in a 1:1 ratio using computer-generated mixed block randomization, stratified by pathological nodal stage, method of axillary evaluation, primary tumor location, and breast cancer molecular subtype. Randomization will be performed at the time of radiotherapy simulation.
Both treatment groups will receive radiotherapy to the breast or chest wall and regional lymph nodes according to protocol-defined target delineation and dose constraints. The experimental group will additionally receive irradiation of the internal mammary lymph nodes, encompassing the first through third intercostal spaces, whereas the control group will undergo intentional omission of IMNI. Three-dimensional conformal radiotherapy or more advanced techniques will be used, with deep inspiration breath-hold permitted to minimize radiation exposure to surrounding normal tissues.
Participants will undergo scheduled clinical follow-up to assess disease recurrence, survival, and treatment-related adverse effects. Particular attention will be given to cardiac and pulmonary toxicity because of the potential increase in radiation exposure associated with IMNI.
An independent Data and Safety Monitoring Board will oversee participant safety and trial conduct. A prespecified interim efficacy analysis will be performed after approximately 50% of the required primary endpoint events have occurred, with additional monitoring for unexpected oncologic harm and serious treatment-related toxicity.
The trial aims to provide prospective evidence to guide individualized decision-making regarding IMNI in patients with residual nodal disease following contemporary neoadjuvant systemic therapy.
- Conditions
- Breast Neoplasms
- Being tested
- Locoregional Radiotherapy With Internal Mammary Node Irradiation, Locoregional Radiotherapy Without Internal Mammary Node Irradiation
- Keywords
- Internal mammary node irradiation, IMNI, Regional nodal irradiation, Neoadjuvant systemic therapy, Node-positive breast cancer, Breast 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.
Locoregional Radiotherapy With Internal Mammary Node IrradiationRadiation
Also called IMNI Group
Adjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, including the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol.
Locoregional Radiotherapy Without Internal Mammary Node IrradiationRadiation
Also called Non-IMNI Group
Adjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, with intentional omission of the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| IMNI Group | Experimental | Participants will receive adjuvant locoregional radiotherapy including irradiation of the internal mammary lymph nodes. Receives: Radiation: Locoregional Radiotherapy With Internal Mammary Node Irradiation |
| Non-IMNI Group | Active comparator | Participants will receive adjuvant radiotherapy to the breast or chest wall and regional lymph nodes without irradiation of the internal mammary lymph nodes. Receives: Radiation: Locoregional Radiotherapy Without Internal Mammary Node Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Disease-free survival is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
Measured: From randomization through 5 years
Secondary outcomes (6)
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Measured: Up to 5 years after randomization
Breast Cancer Mortality
Breast cancer mortality is defined as the time from randomization to death attributable to breast cancer.
Measured: Up to 5 years after randomization
Locoregional Recurrence-Free Survival (LRFS)
Locoregional recurrence-free survival is defined as the time from randomization to the occurrence of locoregional recurrence.
Measured: Up to 5 years after randomization
Distant Metastasis-Free Survival (DMFS)
Distant metastasis-free survival is defined as the time from randomization to the occurrence of distant metastasis.
Measured: Up to 5 years after randomization
Incidence and Severity of Cardiac Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
Acute cardiac toxicity will be assessed using the RTOG Acute Radiation Morbidity Scoring Criteria, while late cardiac toxicity will be assessed using the RTOG/EORTC Late Radiation Morbidity Scoring Schema. Toxicity will be graded from 0 (no toxicity) to 5 (death related to toxicity). The incidence and severity of cardiac toxicity will be compared between treatment groups.
Measured: Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years
Incidence and Severity of Pulmonary Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
Acute pulmonary toxicity will be assessed using the RTOG Acute Radiation Morbidity Scoring Criteria, while late pulmonary toxicity will be assessed using the RTOG/EORTC Late Radiation Morbidity Scoring Schema. Toxicity will be graded from 0 (no toxicity) to 5 (death related to toxicity). The incidence and severity of pulmonary toxicity will be compared between the two treatment groups.
Measured: Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jul 2027 (estimated)
- Primary completion1 Jul 2032 (estimated)
- Study completion1 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915739
- Sponsor's protocol ID
- 587/2569(IRB2)
- Acronym
- IMN-Neo
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
CHEN Yuguang, S. X., BI Zhao, QIU Pengfei, DUAN Baowei, FAN Qingda, WANG Yongsheng. Internal mammary sentinel lymph node biopsy for breast cancer: a long-term follow-up research for assessment of prognosis and guiding individualized internal mammary lymph node irradiation. China Oncology 33, 142-151, doi:10.19401/j.cnki.1007-3639.2023.02.007 (2023).
Luo J, Jin K, Chen X, Wang X, Yang Z, Zhang L, Mei X, Ma J, Zhang X, Zhou Z, Wang X, Jiang Y, Shao Z, Zhang Z, Guo X, Yu X. Internal Mammary Node Irradiation (IMNI) Improves Survival Outcome for Patients With Clinical Stage II-III Breast Cancer After Preoperative Systemic Therapy. Int J Radiat Oncol Biol Phys. 2019 Mar 15;103(4):895-904. doi: 10.1016/j.ijrobp.2018.11.003. Epub 2018 Nov 12.
PubMed 30439485Kim KH, Noh JM, Kim YB, Chang JS, Keum KC, Huh SJ, Choi DH, Park W, Suh CO. Does internal mammary node irradiation affect treatment outcome in clinical stage II-III breast cancer patients receiving neoadjuv ant chemotherapy? Breast Cancer Res Treat. 2015 Aug;152(3):589-99. doi: 10.1007/s10549-015-3505-1. Epub 2015 Jul 23.
PubMed 26202053Nielsen AWM, Thorsen LBJ, Ozcan D, Matthiessen LW, Maae E, Milo MLH, Nielsen MH, Tramm T, Overgaard J, Offersen BV; DBCG RT Committee. Internal mammary node irradiation in 4541 node-positive breast cancer patients treated with newer systemic therapies and 3D-based radiotherapy (DBCG IMN2): a prospective, nationwide, population-based cohort study. Lancet Reg Health Eur. 2024 Dec 12;49:101160. doi: 10.1016/j.lanepe.2024.101160. eCollection 2025 Feb.
PubMed 39810969Thorsen LB, Offersen BV, Dano H, Berg M, Jensen I, Pedersen AN, Zimmermann SJ, Brodersen HJ, Overgaard M, Overgaard J. DBCG-IMN: A Population-Based Cohort Study on the Effect of Internal Mammary Node Irradiation in Early Node-Positive Breast Cancer. J Clin Oncol. 2016 Feb 1;34(4):314-20. doi: 10.1200/JCO.2015.63.6456. Epub 2015 Nov 23.
PubMed 26598752Mamounas EP, Bandos H, White JR, Julian TB, Khan AJ, Shaitelman SF, Torres MA, Vicini FA, Ganz PA, McCloskey SA, Lucas PC, Gupta N, Li XA, McCormick B, Smith B, Tendulkar RD, Kavadi VS, Matsumoto K, Seaward SA, Irvin WJ Jr, Lin JY, Mutter RW, Muanza TM, Stromberg J, Jagsi R, Weiss AC, Curran WJ Jr, Wolmark N. Omitting Regional Nodal Irradiation after Response to Neoadjuvant Chemotherapy. N Engl J Med. 2025 Jun 5;392(21):2113-2124. doi: 10.1056/NEJMoa2414859.
PubMed 40466065Kaidar-Person O, Fortpied C, Hol S, Weltens C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, Weidner N, Guckenberger M, Koiter E, Fourquet A, Bartelink H, Struikmans H, Poortmans P; EORTC Radiation Oncology and Breast Cancer Groups. The association of internal mammary and medial supraclavicular lymph node radiation technique with clinical outcomes: Results from the EORTC 22922/10925 randomised trial. Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.
PubMed 35568284Whelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A, Vallis KA, White JR, Rousseau P, Fortin A, Pierce LJ, Manchul L, Chafe S, Nolan MC, Craighead P, Bowen J, McCready DR, Pritchard KI, Gelmon K, Murray Y, Chapman JA, Chen BE, Levine MN; MA.20 Study Investigators. Regional Nodal Irradiation in Early-Stage Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):307-16. doi: 10.1056/NEJMoa1415340.
PubMed 26200977Early Breast Cancer Trialists' Collaborative Group. Electronic address: bc.overview@ctsu.ox.ac.uk. Reductions in recurrence in women with early breast cancer entering clinical trials between 1990 and 2009: a pooled analysis of 155 746 women in 151 trials. Lancet. 2024 Oct 12;404(10461):1407-1418. doi: 10.1016/S0140-6736(24)01745-8.
PubMed 39396348
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Mammary Node Irradiation Versus Omission of Internal Mammary Node Irradiation in Breast Cancer Treated With Neoadjuvant Systemic Therapy: A Phase III Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07915739
- Acronym / sponsor ID
- IMN-Neo / 587/2569(IRB2)
- Conditions
- Breast Neoplasms
- Keywords
- Internal mammary node irradiation, IMNI, Regional nodal irradiation, Neoadjuvant systemic therapy, Node-positive breast cancer, Breast radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,760 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 1 Jul 2036 (estimated)
- First posted
- 4 Nov 2026 (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 multicenter randomized controlled trial evaluates whether internal mammary node irradiation (IMNI) improves oncologic outcomes in patients with breast cancer who have residual pathologically positive lymph nodes after neoadjuvant systemic therapy.
Eligible participants will be randomly assigned in a 1:1 ratio to receive locoregional radiotherapy either with or without irradiation of the internal mammary lymph nodes. The primary outcome is disease-free survival. Secondary outcomes include overall survival, breast cancer mortality, locoregional recurrence-free survival, distant metastasis-free survival, and treatment-related toxicity, particularly cardiac and pulmonary toxicity.
A total of 1,760 participants are planned to be enrolled across multiple centers in Thailand.
Detailed description
Regional nodal irradiation is an established component of adjuvant radiotherapy for selected patients with node-positive breast cancer. However, the additional benefit of internal mammary node irradiation (IMNI) remains uncertain, particularly in patients receiving contemporary neoadjuvant systemic therapy. Although previous randomized trials have demonstrated potential oncologic benefits of regional nodal irradiation incorporating IMNI, most were conducted in patients undergoing upfront surgery, before the widespread use of modern systemic treatments. Consequently, the benefit-risk balance of IMNI in patients with residual nodal disease after neoadjuvant systemic therapy remains unclear.
IMN-Neo is a phase III, multicenter, randomized, open-label superiority trial designed to evaluate whether the addition of IMNI to standard locoregional radiotherapy improves oncologic outcomes in patients with residual pathologically positive axillary lymph nodes following neoadjuvant systemic therapy.
Participants will be randomized in a 1:1 ratio using computer-generated mixed block randomization, stratified by pathological nodal stage, method of axillary evaluation, primary tumor location, and breast cancer molecular subtype. Randomization will be performed at the time of radiotherapy simulation.
Both treatment groups will receive radiotherapy to the breast or chest wall and regional lymph nodes according to protocol-defined target delineation and dose constraints. The experimental group will additionally receive irradiation of the internal mammary lymph nodes, encompassing the first through third intercostal spaces, whereas the control group will undergo intentional omission of IMNI. Three-dimensional conformal radiotherapy or more advanced techniques will be used, with deep inspiration breath-hold permitted to minimize radiation exposure to surrounding normal tissues.
Participants will undergo scheduled clinical follow-up to assess disease recurrence, survival, and treatment-related adverse effects. Particular attention will be given to cardiac and pulmonary toxicity because of the potential increase in radiation exposure associated with IMNI.
An independent Data and Safety Monitoring Board will oversee participant safety and trial conduct. A prespecified interim efficacy analysis will be performed after approximately 50% of the required primary endpoint events have occurred, with additional monitoring for unexpected oncologic harm and serious treatment-related toxicity.
The trial aims to provide prospective evidence to guide individualized decision-making regarding IMNI in patients with residual nodal disease following contemporary neoadjuvant systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMNI Group | Experimental | Radiation: Locoregional Radiotherapy With Internal Mammary Node IrradiationParticipants will receive adjuvant locoregional radiotherapy including irradiation of the internal mammary lymph nodes. |
| Non-IMNI Group | Active comparator | Radiation: Locoregional Radiotherapy Without Internal Mammary Node IrradiationParticipants will receive adjuvant radiotherapy to the breast or chest wall and regional lymph nodes without irradiation of the internal mammary lymph nodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed breast cancer with pathologically proven lymph node positivity after neoadjuvant systemic therapy.
- Received neoadjuvant chemotherapy and/or targeted therapy and/or immunotherapy before surgery.
- Underwent either breast-conserving surgery or mastectomy with lymph node evaluation and is planned to receive adjuvant locoregional radiotherapy.
- Planned treatment with three-dimensional conformal radiotherapy (3D-CRT) or a more advanced radiotherapy technique.
- Female ≥ 18 years
Key exclusion criteria (7 listed)
- Clinical or radiologic evidence of internal mammary lymph node involvement of any size.
- Inflammatory breast cancer.
- Bilateral breast cancer.
- Multiple primary malignancies, except basal cell carcinoma and premalignant gynecologic lesions including CIN, HSIL, LSIL, VIN, and VAIN.
- Prior chest irradiation.
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 |
|---|---|---|
| Locoregional Radiotherapy With Internal Mammary Node IrradiationAlso: IMNI GroupAdjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, including the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol. | Radiation | IMNI Group |
| Locoregional Radiotherapy Without Internal Mammary Node IrradiationAlso: Non-IMNI GroupAdjuvant locoregional radiotherapy to the breast or chest wall and regional lymph nodes, with intentional omission of the internal mammary lymph nodes. Allowed dose-fractionation schedules include 50 Gy in 25 fractions, 42.5 Gy in 16 fractions, or 40 Gy in 15 fractions, according to the study protocol. | Radiation | Non-IMNI Group |
Primary outcome
Disease-Free Survival (DFS)
Time frame: From randomization through 5 years
Disease-free survival is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 years after randomization
Breast Cancer Mortality
Time frame: Up to 5 years after randomization
Locoregional Recurrence-Free Survival (LRFS)
Time frame: Up to 5 years after randomization
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to 5 years after randomization
Incidence and Severity of Cardiac Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
Time frame: Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 years
Incidence and Severity of Pulmonary Toxicity Assessed Using RTOG/EORTC Radiation Morbidity Scoring Criteria
Time frame: Last week of radiotherapy, then at 1, 3, and 6 months, and every 6 months through 2 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 4 Nov 2026.
- BackgroundCHEN Yuguang, S. X., BI Zhao, QIU Pengfei, DUAN Baowei, FAN Qingda, WANG Yongsheng. Internal mammary sentinel lymph node biopsy for breast cancer: a long-term follow-up research for assessment of prognosis and guiding individualized internal mammary lymph node irradiation. China Oncology 33, 142-151, doi:10.19401/j.cnki.1007-3639.2023.02.007 (2023).
- Background: PubMed 30439485Luo J, Jin K, Chen X, Wang X, Yang Z, Zhang L, Mei X, Ma J, Zhang X, Zhou Z, Wang X, Jiang Y, Shao Z, Zhang Z, Guo X, Yu X. Internal Mammary Node Irradiation (IMNI) Improves Survival Outcome for Patients With Clinical Stage II-III Breast Cancer After Preoperative Systemic Therapy. Int J Radiat Oncol Biol Phys. 2019 Mar 15;103(4):895-904. doi: 10.1016/j.ijrobp.2018.11.003. Epub 2018 Nov 12.
- Background: PubMed 26202053Kim KH, Noh JM, Kim YB, Chang JS, Keum KC, Huh SJ, Choi DH, Park W, Suh CO. Does internal mammary node irradiation affect treatment outcome in clinical stage II-III breast cancer patients receiving neoadjuv ant chemotherapy? Breast Cancer Res Treat. 2015 Aug;152(3):589-99. doi: 10.1007/s10549-015-3505-1. Epub 2015 Jul 23.
- Background: PubMed 39810969Nielsen AWM, Thorsen LBJ, Ozcan D, Matthiessen LW, Maae E, Milo MLH, Nielsen MH, Tramm T, Overgaard J, Offersen BV; DBCG RT Committee. Internal mammary node irradiation in 4541 node-positive breast cancer patients treated with newer systemic therapies and 3D-based radiotherapy (DBCG IMN2): a prospective, nationwide, population-based cohort study. Lancet Reg Health Eur. 2024 Dec 12;49:101160. doi: 10.1016/j.lanepe.2024.101160. eCollection 2025 Feb.
- Background: PubMed 26598752Thorsen LB, Offersen BV, Dano H, Berg M, Jensen I, Pedersen AN, Zimmermann SJ, Brodersen HJ, Overgaard M, Overgaard J. DBCG-IMN: A Population-Based Cohort Study on the Effect of Internal Mammary Node Irradiation in Early Node-Positive Breast Cancer. J Clin Oncol. 2016 Feb 1;34(4):314-20. doi: 10.1200/JCO.2015.63.6456. Epub 2015 Nov 23.
- Background: PubMed 40466065Mamounas EP, Bandos H, White JR, Julian TB, Khan AJ, Shaitelman SF, Torres MA, Vicini FA, Ganz PA, McCloskey SA, Lucas PC, Gupta N, Li XA, McCormick B, Smith B, Tendulkar RD, Kavadi VS, Matsumoto K, Seaward SA, Irvin WJ Jr, Lin JY, Mutter RW, Muanza TM, Stromberg J, Jagsi R, Weiss AC, Curran WJ Jr, Wolmark N. Omitting Regional Nodal Irradiation after Response to Neoadjuvant Chemotherapy. N Engl J Med. 2025 Jun 5;392(21):2113-2124. doi: 10.1056/NEJMoa2414859.
- Background: PubMed 35568284Kaidar-Person O, Fortpied C, Hol S, Weltens C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, Weidner N, Guckenberger M, Koiter E, Fourquet A, Bartelink H, Struikmans H, Poortmans P; EORTC Radiation Oncology and Breast Cancer Groups. The association of internal mammary and medial supraclavicular lymph node radiation technique with clinical outcomes: Results from the EORTC 22922/10925 randomised trial. Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.
- Background: PubMed 26200977Whelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A, Vallis KA, White JR, Rousseau P, Fortin A, Pierce LJ, Manchul L, Chafe S, Nolan MC, Craighead P, Bowen J, McCready DR, Pritchard KI, Gelmon K, Murray Y, Chapman JA, Chen BE, Levine MN; MA.20 Study Investigators. Regional Nodal Irradiation in Early-Stage Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):307-16. doi: 10.1056/NEJMoa1415340.
- Background: PubMed 39396348Early Breast Cancer Trialists' Collaborative Group. Electronic address: bc.overview@ctsu.ox.ac.uk. Reductions in recurrence in women with early breast cancer entering clinical trials between 1990 and 2009: a pooled analysis of 155 746 women in 151 trials. Lancet. 2024 Oct 12;404(10461):1407-1418. doi: 10.1016/S0140-6736(24)01745-8.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Locoregional Radiotherapy With Internal Mammary Node Irradiation and Locoregional Radiotherapy Without Internal Mammary Node Irradiation in people with Breast Neoplasms, run by Mahidol University at 9 sites in Thailand.
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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tanun Jitwatcharakomol, MD (+66909623000, tanun.jit@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: From randomization through 5 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 NCT07915739, which also lists 9 linked publications.
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 4 Nov 2026; AzTrials last refreshed its copy on 4 Nov 2026.