Breast CancerPhase 2DEMANDNCT07643584
De-Escalation of Axillary Management in Advanced Nodal Disease
A Phase 2 study testing Axillary Surgery in people with Breast Cancer, run by University of Kansas Medical Center.
Trial summary
This is a prospective, phase 2, single arm trial to evaluate whether Axillary Lymph Node Dissection (ALND) can be safely omitted for patients with cN2 and cN3 breast cancer who achieve a complete clinical response on exam with a complete or partial response by end-of-treatment (EOT) imaging and have either a partial… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Axillary Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2031
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE Remote consenting allowed per IRB policy and approval.
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Males and/or females age ≥ 18 to 80 years
- Clinical stage T1-3 N2-3 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy).
- All patients must have had an axillary ultrasound with FNA or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy.
- Patients must have had estrogen receptor, progesterone receptor and HER2 status (by IHC and/or ISH) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy. Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled (see exclusion criteria).
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- Patients must have completed planned chemotherapy (neoadjuvant chemotherapy [NAC]) prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery). Adjuvant systemic therapy based on final surgical pathology is allowed and at the discretion of the treating medical oncologist. Note: Delays/dose modifications due to toxicities/adverse events are allowed per the treating medical oncologist.
- Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be FDA-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an IRB-approved clinical trial.
- Benign breast disease, LCIS or DCIS of contralateral breast is allowed
- All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy. Note: A partial or complete imaging response that includes all lymph nodes measuring ≤ 1cm clinically is required for eligibility.
- ECOG (Zubrod) Performance Status 0-1 (Appendix A)
- Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy. Negative margin (by either breast conservation or mastectomy) on final pathology where negative margin is defined as no tumor on ink.
- Females of childbearing potential must have a negative serum pregnancy test performed - according to institutional standard of care prior to surgery.
- Females of child-bearing potential and males with partners of child-bearing potential must agree not to donate sperm, to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and, following the last administration of therapy , for as long as directed per standard or care chemotherapy (investigational regimen allowed) and radiation therapy, whichever is longer. Note: Peri-menopausal women must be amenorrheic for ≥ 12 months to be considered not of childbearing potential.
- Definition of medically fit for surgery:
- ECOG status of 0-1
- NOTE - participants are eligible for surgery if they have nicotine in the blood or high A1c. These values will be monitored per SOC.
Who cannot join
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements and / or giving informed consent.
- Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this study unreasonably hazardous for the patient.
- Inflammatory breast cancer.
- Any other malignancy within 5 years of enrollment with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
- HER2 status has not been clearly determined (i.e. equivocal/indeterminate)
- Patient has had neoadjuvant endocrine therapy > than 8 weeks prior to the start of neoadjuvant chemotherapy.
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- Neoadjuvant radiation therapy.
- SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy.
- Prior history of ipsilateral breast cancer (invasive disease or DCIS). NOTE LCIS and benign breast disease is allowed.
- Prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
- History of prior or concurrent contralateral invasive breast cancer. .
- Patient pregnant or nursing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DEMAND - A Phase II Trial of De-Escalation of Axillary Management in Advanced Nodal Disease
This is a prospective, phase 2, single arm trial to evaluate whether Axillary Lymph Node Dissection (ALND) can be safely omitted for patients with cN2 and cN3 breast cancer who achieve a complete clinical response on exam with a complete or partial response by end-of-treatment (EOT) imaging and have either a partial or complete pathologic nodal response after neoadjuvant chemotherapy (NAC) by performing nodal assessment of sentinel lymph node surgery (with or without targeted axillary dissection (TAD) followed by Regional Nodal Irradiation (RNI).
This study aims to demonstrate that performing only a sentinel node dissection, which includes the removal of palpably gross disease followed by radiation, will not impact distant disease and thus survival.
- Conditions
- Breast Cancer
- Being tested
- Axillary Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary SurgeryProcedure or surgery
Patients who are clinically node negative after neoadjuvant chemotherapy by physical examination will undergo clinically indicated breast surgery (mastectomy or lumpectomy) with sentinel lymph node (SLN) surgery. Sentinel lymph node surgery must be performed within 8 weeks (56 days) after completion of the last dose of neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Axillary Surgery | Experimental | Not described Receives: Procedure: Axillary Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
To determine if radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with regional nodal irradiation (excluding dissected axilla) for DFS after neoadjuvant chemotherapy response. DFS assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: 5 years
Secondary outcomes (6)
Invasive Breast Cancer Recurrence Free Interval (IBC - RFI)
To assess if radiation to the undissected axilla and regional nodes is not inferior to axillary dissection plus regional nodal radiation for IBC-RFI, DSS, and LRR in patients with complete or partial response to neoadjuvant chemotherapy. Determined by medical record.
Measured: 5 years
Disease Specific Survival (DSS)
To assess if radiation to the undissected axilla and regional nodes is not inferior to axillary dissection plus regional nodal radiation for IBC-RFI, DSS, and LRR in patients with complete or partial response to neoadjuvant chemotherapy. Determined by medical record.
Measured: 5 years
Locoregional Recurrence (LRR)
To assess if radiation to the undissected axilla and regional nodes is not inferior to axillary dissection plus regional nodal radiation for IBC-RFI, DSS, and LRR in patients with complete or partial response to neoadjuvant chemotherapy. Determined by medical record.
Measured: 5 years
Lymphedema Incidence
To estimate the incidence of arm lymphedema in participants that undergo SLN with comprehensive RNI. Determined by Bioimpedance Spectroscopy
Measured: Measured at 9 months, annually, and PRN (as needed) per patient reported symptoms, over a duration of approximately 5 years.
Recurrence Cancer Burden (RCB) Score
To estimate the distribution or Recurrence Cancer Burden (RCB) Score
Measured: Measured at final surgical pathology (up to 21 days after surgery)
Imaging positive predictive value for extent of nodal disease burden compared to final surgical pathology and lab draws
Assessed by MRI, US, and final surgical pathology. The same imaging modality used to assess nodal adenopathy at baseline must be used throughout. RECIST v 1.1 criteria will be used for assessments.
Measured: Measured at final surgical pathology (up to 21 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Wagner, D.O., University of Kansas Medical Center
- Investigators
- Jamie Wagner, D.O., Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643584
- Sponsor's protocol ID
- IIT-2025-DEMAND
- Acronym
- DEMAND
- Status last verified
- Oct 2026
- First submitted
- 29 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim EJ, Yoo TK, Kim J, Chung IY, Ko BS, Kim HJ, Lee JW, Son BH, Lee SB. Feasibility of de-escalating axillary surgery in patients with clinical N2-3, pathological N0 breast cancer after neoadjuvant chemotherapy. Sci Rep. 2025 Apr 1;15(1):11128. doi: 10.1038/s41598-024-84841-y.
PubMed 40169643Cabioglu N, Kocer HB, Karanlik H, Gulcelik MA, Igci A, Muslumanoglu M, Uras C, Mantoglu B, Trabulus DC, Akgul G, Tukenmez M, Senol K, Ozkurt E, Sen E, Karadeniz Cakmak G, Bademler S, Emiroglu S, Yildirim N, Kara H, Dag A, Dilege E, Altinok A, Basaran G, Varol E, Ugurlu U, Bolukbasi Y, Ersoy YE, Zengel B, Karaman N, Ozbas S, Zer L, Gul Kilic H, Agcaoglu O, Sakman G, Utkan Z, Soyder A, Akcan A, Ergun S, Yilmaz R, Aydiner A, Soran A, Ibis K, Ozmen V. De-Escalation of Nodal Surgery in Clinically Node-Positive Breast Cancer. JAMA Surg. 2025 Mar 1;160(3):257-266. doi: 10.1001/jamasurg.2024.5913.
PubMed 39745737Muslumanoglu M, Cabioglu N, Igci A, Karanlik H, Kocer HB, Senol K, Mantoglu B, Tukenmez M, Cakmak GK, Ozkurt E, Gulcelik MA, Emiroglu S, Mollavelioglu B, Yildirim N, Bademler S, Zengel B, Trabulus DC, Ugurlu MU, Uras C, Ilgun S, Akgul GG, Akcan A, Yormaz S, Ersoy YE, Ozbas S, Dilege E, Citgez B, Bolukbasi Y, Altinok A, Dag A, Basaran G, Utkan NZ, Ozcinar B, Arici C, AlJorani I, Kara H, Yigit B, Sen E, Erozgen F, Soyder A, Celik B, Kilic HG, Zer L, Sakman G, Yeniay L, Atahan K, Varol E, Veliyeva V, Goktepe B, Velidedeoglu M, Karaman N, Soran A, Aydiner A, Yilmaz R, Ibis K, Ozmen V. Combined analysis of the MF18-02/MF18-03 NEOSENTITURK studies: ypN-positive disease does not necessitate axillary lymph node dissection in patients with breast cancer with a good response to neoadjuvant chemotherapy as long as radiotherapy is provided. Cancer. 2025 Jan 1;131(1):e35610. doi: 10.1002/cncr.35610. Epub 2024 Oct 30.
PubMed 39476303Vega, R M, Deladisma AM, Mobley E M, et al., Axillary surgery efficacy for patients with breast cancer receiving neoadjuvant chemotherapy on NSABP B40 and B41. 2023, Journal of Clinical Oncology: J Clin Oncol 41, 2023 (suppl 16; abstr 524).
Montagna G, Mrdutt MM, Sun SX, Hlavin C, Diego EJ, Wong SM, Barrio AV, van den Bruele AB, Cabioglu N, Sevilimedu V, Rosenberger LH, Hwang ES, Ingham A, Papassotiropoulos B, Nguyen-Strauli BD, Kurzeder C, Aybar DD, Vorburger D, Matlac DM, Ostapenko E, Riedel F, Fitzal F, Meani F, Fick F, Sagasser J, Heil J, Karanlik H, Dedes KJ, Romics L, Banys-Paluchowski M, Muslumanoglu M, Perez MDRC, Diaz MC, Heidinger M, Fehr MK, Reinisch M, Tukenmez M, Maggi N, Rocco N, Ditsch N, Gentilini OD, Paulinelli RR, Zarhi SS, Kuemmel S, Bruzas S, di Lascio S, Parissenti TK, Hoskin TL, Guth U, Ovalle V, Tausch C, Kuerer HM, Caudle AS, Boileau JF, Boughey JC, Kuhn T, Morrow M, Weber WP. Omission of Axillary Dissection Following Nodal Downstaging With Neoadjuvant Chemotherapy. JAMA Oncol. 2024 Jun 1;10(6):793-798. doi: 10.1001/jamaoncol.2024.0578.
PubMed 38662396Brackstone M, Baldassarre FG, Perera FE, Cil T, Chavez Mac Gregor M, Dayes IS, Engel J, Horton JK, King TA, Kornecki A, George R, SenGupta SK, Spears PA, Eisen AF. Management of the Axilla in Early-Stage Breast Cancer: Ontario Health (Cancer Care Ontario) and ASCO Guideline. J Clin Oncol. 2021 Sep 20;39(27):3056-3082. doi: 10.1200/JCO.21.00934. Epub 2021 Jul 19.
PubMed 34279999Cabioglu N, Karanlik H, Yildirim N, Muslumanoglu M, Cakmak Karadeniz G, Trabulus Can D, Tukenmez M, Ersoy YE, Uras C, Zengel B, Emiroglu S, Polat AK, Yeniay L, Ozkurt E, Kara H, Ibis K, Aydiner A, Ozmen V, Igci A. Favorable outcome with sentinel lymph node biopsy alone after neoadjuvant chemotherapy in clinically node positive breast cancer at diagnosis: Turkish Multicentric NEOSENTI-TURK MF-18-02-study. Eur J Surg Oncol. 2021 Oct;47(10):2506-2514. doi: 10.1016/j.ejso.2021.06.024. Epub 2021 Jun 24.
PubMed 34217580Pilewskie M, Morrow M. Axillary Nodal Management Following Neoadjuvant Chemotherapy: A Review. JAMA Oncol. 2017 Apr 1;3(4):549-555. doi: 10.1001/jamaoncol.2016.4163.
PubMed 27918753Recht A, Comen EA, Fine RE, Fleming GF, Hardenbergh PH, Ho AY, Hudis CA, Hwang ES, Kirshner JJ, Morrow M, Salerno KE, Sledge GW Jr, Solin LJ, Spears PA, Whelan TJ, Somerfield MR, Edge SB. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol. 2016 Nov-Dec;6(6):e219-e234. doi: 10.1016/j.prro.2016.08.009. Epub 2016 Sep 19.
PubMed 27659727Huang EH, Tucker SL, Strom EA, McNeese MD, Kuerer HM, Hortobagyi GN, Buzdar AU, Valero V, Perkins GH, Schechter NR, Hunt KK, Sahin AA, Buchholz TA. Predictors of locoregional recurrence in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy, mastectomy, and radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):351-7. doi: 10.1016/j.ijrobp.2004.09.056.
PubMed 15890574Mamounas EP. Impact of neoadjuvant chemotherapy on locoregional surgical treatment of breast cancer. Ann Surg Oncol. 2015 May;22(5):1425-33. doi: 10.1245/s10434-015-4406-6. Epub 2015 Mar 2.
PubMed 25727558Gerber B, Schneeweiss A, Mobus V, Golatta M, Tesch H, Krug D, Hanusch C, Denkert C, Lubbe K, Heil J, Huober J, Ataseven B, Klare P, Hahn M, Untch M, Kast K, Jackisch C, Thomalla J, Seither F, Blohmer JU, Rhiem K, Fasching PA, Nekljudova V, Loibl S, Kuhn T. Pathological Response in the Breast and Axillary Lymph Nodes after Neoadjuvant Systemic Treatment in Patients with Initially Node-Positive Breast Cancer Correlates with Disease Free Survival: An Exploratory Analysis of the GeparOcto Trial. Cancers (Basel). 2022 Jan 20;14(3):521. doi: 10.3390/cancers14030521.
PubMed 35158789Guo L, Xie G, Wang R, Yang L, Sun L, Xu M, Yang W, Chung MC. Local treatment for triple-negative breast cancer patients undergoing chemotherapy: breast-conserving surgery or total mastectomy? BMC Cancer. 2021 Jun 19;21(1):717. doi: 10.1186/s12885-021-08429-9.
PubMed 34147061Kuemmel S, Heil J, Bruzas S, Breit E, Schindowski D, Harrach H, Chiari O, Hellerhoff K, Bensmann E, Hanf V, Grasshoff ST, Deuschle P, Belke K, Polata S, Paepke S, Warm M, Meiler J, Schindlbeck C, Ruhwedel W, Beckmann U, Groh U, Dall P, Blohmer JU, Traut A, Reinisch M. Safety of Targeted Axillary Dissection After Neoadjuvant Therapy in Patients With Node-Positive Breast Cancer. JAMA Surg. 2023 Aug 1;158(8):807-815. doi: 10.1001/jamasurg.2023.1772.
PubMed 37285140Mamounas 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 40466065
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEMAND - A Phase II Trial of De-Escalation of Axillary Management in Advanced Nodal Disease
- ClinicalTrials.gov ID
- NCT07643584
- Acronym / sponsor ID
- DEMAND / IIT-2025-DEMAND
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 11 Jun 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 is a prospective, phase 2, single arm trial to evaluate whether Axillary Lymph Node Dissection (ALND) can be safely omitted for patients with cN2 and cN3 breast cancer who achieve a complete clinical response on exam with a complete or partial response by end-of-treatment (EOT) imaging and have either a partial or complete pathologic nodal response after neoadjuvant chemotherapy (NAC) by performing nodal assessment of sentinel lymph node surgery (with or without targeted axillary dissection (TAD) followed by Regional Nodal Irradiation (RNI).
This study aims to demonstrate that performing only a sentinel node dissection, which includes the removal of palpably gross disease followed by radiation, will not impact distant disease and thus survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axillary Surgery | Experimental | Procedure: Axillary Surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE Remote consenting allowed per IRB policy and approval.
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Males and/or females age ≥ 18 to 80 years
- Clinical stage T1-3 N2-3 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy).
- All patients must have had an axillary ultrasound with FNA or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy.
Key exclusion criteria (12 listed)
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements and / or giving informed consent.
- Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this study unreasonably hazardous for the patient.
- Inflammatory breast cancer.
- Any other malignancy within 5 years of enrollment with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
- HER2 status has not been clearly determined (i.e. equivocal/indeterminate)
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 |
|---|---|---|
| Axillary SurgeryPatients who are clinically node negative after neoadjuvant chemotherapy by physical examination will undergo clinically indicated breast surgery (mastectomy or lumpectomy) with sentinel lymph node (SLN) surgery. Sentinel lymph node surgery must be performed within 8 weeks (56 days) after completion of the last dose of neoadjuvant chemotherapy. | Procedure or surgery | Axillary Surgery |
Primary outcome
Disease Free Survival (DFS)
Time frame: 5 years
To determine if radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with regional nodal irradiation (excluding dissected axilla) for DFS after neoadjuvant chemotherapy response. DFS assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
6 secondary outcomes
Invasive Breast Cancer Recurrence Free Interval (IBC - RFI)
Time frame: 5 years
Disease Specific Survival (DSS)
Time frame: 5 years
Locoregional Recurrence (LRR)
Time frame: 5 years
Lymphedema Incidence
Time frame: Measured at 9 months, annually, and PRN (as needed) per patient reported symptoms, over a duration of approximately 5 years.
Recurrence Cancer Burden (RCB) Score
Time frame: Measured at final surgical pathology (up to 21 days after surgery)
Imaging positive predictive value for extent of nodal disease burden compared to final surgical pathology and lab draws
Time frame: Measured at final surgical pathology (up to 21 days after surgery)
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 16 Oct 2026.
- Background: PubMed 40169643Kim EJ, Yoo TK, Kim J, Chung IY, Ko BS, Kim HJ, Lee JW, Son BH, Lee SB. Feasibility of de-escalating axillary surgery in patients with clinical N2-3, pathological N0 breast cancer after neoadjuvant chemotherapy. Sci Rep. 2025 Apr 1;15(1):11128. doi: 10.1038/s41598-024-84841-y.
- Background: PubMed 39745737Cabioglu N, Kocer HB, Karanlik H, Gulcelik MA, Igci A, Muslumanoglu M, Uras C, Mantoglu B, Trabulus DC, Akgul G, Tukenmez M, Senol K, Ozkurt E, Sen E, Karadeniz Cakmak G, Bademler S, Emiroglu S, Yildirim N, Kara H, Dag A, Dilege E, Altinok A, Basaran G, Varol E, Ugurlu U, Bolukbasi Y, Ersoy YE, Zengel B, Karaman N, Ozbas S, Zer L, Gul Kilic H, Agcaoglu O, Sakman G, Utkan Z, Soyder A, Akcan A, Ergun S, Yilmaz R, Aydiner A, Soran A, Ibis K, Ozmen V. De-Escalation of Nodal Surgery in Clinically Node-Positive Breast Cancer. JAMA Surg. 2025 Mar 1;160(3):257-266. doi: 10.1001/jamasurg.2024.5913.
- Background: PubMed 39476303Muslumanoglu M, Cabioglu N, Igci A, Karanlik H, Kocer HB, Senol K, Mantoglu B, Tukenmez M, Cakmak GK, Ozkurt E, Gulcelik MA, Emiroglu S, Mollavelioglu B, Yildirim N, Bademler S, Zengel B, Trabulus DC, Ugurlu MU, Uras C, Ilgun S, Akgul GG, Akcan A, Yormaz S, Ersoy YE, Ozbas S, Dilege E, Citgez B, Bolukbasi Y, Altinok A, Dag A, Basaran G, Utkan NZ, Ozcinar B, Arici C, AlJorani I, Kara H, Yigit B, Sen E, Erozgen F, Soyder A, Celik B, Kilic HG, Zer L, Sakman G, Yeniay L, Atahan K, Varol E, Veliyeva V, Goktepe B, Velidedeoglu M, Karaman N, Soran A, Aydiner A, Yilmaz R, Ibis K, Ozmen V. Combined analysis of the MF18-02/MF18-03 NEOSENTITURK studies: ypN-positive disease does not necessitate axillary lymph node dissection in patients with breast cancer with a good response to neoadjuvant chemotherapy as long as radiotherapy is provided. Cancer. 2025 Jan 1;131(1):e35610. doi: 10.1002/cncr.35610. Epub 2024 Oct 30.
- BackgroundVega, R M, Deladisma AM, Mobley E M, et al., Axillary surgery efficacy for patients with breast cancer receiving neoadjuvant chemotherapy on NSABP B40 and B41. 2023, Journal of Clinical Oncology: J Clin Oncol 41, 2023 (suppl 16; abstr 524).
- Background: PubMed 38662396Montagna G, Mrdutt MM, Sun SX, Hlavin C, Diego EJ, Wong SM, Barrio AV, van den Bruele AB, Cabioglu N, Sevilimedu V, Rosenberger LH, Hwang ES, Ingham A, Papassotiropoulos B, Nguyen-Strauli BD, Kurzeder C, Aybar DD, Vorburger D, Matlac DM, Ostapenko E, Riedel F, Fitzal F, Meani F, Fick F, Sagasser J, Heil J, Karanlik H, Dedes KJ, Romics L, Banys-Paluchowski M, Muslumanoglu M, Perez MDRC, Diaz MC, Heidinger M, Fehr MK, Reinisch M, Tukenmez M, Maggi N, Rocco N, Ditsch N, Gentilini OD, Paulinelli RR, Zarhi SS, Kuemmel S, Bruzas S, di Lascio S, Parissenti TK, Hoskin TL, Guth U, Ovalle V, Tausch C, Kuerer HM, Caudle AS, Boileau JF, Boughey JC, Kuhn T, Morrow M, Weber WP. Omission of Axillary Dissection Following Nodal Downstaging With Neoadjuvant Chemotherapy. JAMA Oncol. 2024 Jun 1;10(6):793-798. doi: 10.1001/jamaoncol.2024.0578.
- Background: PubMed 34279999Brackstone M, Baldassarre FG, Perera FE, Cil T, Chavez Mac Gregor M, Dayes IS, Engel J, Horton JK, King TA, Kornecki A, George R, SenGupta SK, Spears PA, Eisen AF. Management of the Axilla in Early-Stage Breast Cancer: Ontario Health (Cancer Care Ontario) and ASCO Guideline. J Clin Oncol. 2021 Sep 20;39(27):3056-3082. doi: 10.1200/JCO.21.00934. Epub 2021 Jul 19.
- Background: PubMed 34217580Cabioglu N, Karanlik H, Yildirim N, Muslumanoglu M, Cakmak Karadeniz G, Trabulus Can D, Tukenmez M, Ersoy YE, Uras C, Zengel B, Emiroglu S, Polat AK, Yeniay L, Ozkurt E, Kara H, Ibis K, Aydiner A, Ozmen V, Igci A. Favorable outcome with sentinel lymph node biopsy alone after neoadjuvant chemotherapy in clinically node positive breast cancer at diagnosis: Turkish Multicentric NEOSENTI-TURK MF-18-02-study. Eur J Surg Oncol. 2021 Oct;47(10):2506-2514. doi: 10.1016/j.ejso.2021.06.024. Epub 2021 Jun 24.
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- 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.
Jamie Wagner, D.O. principal investigator
The University of Kansas Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axillary Surgery in people with Breast Cancer, run by University of Kansas Medical Center.
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 17 inclusion and 12 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 KUCC Navigation ((913) 588-3671, kucc_navigation@kumc.edu), 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: 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 NCT07643584, which also lists 28 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 16 Oct 2026.