De-Escalation of Axillary Management in Advanced Nodal Disease

NCT07643584 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IIT-2025-DEMAND
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (6)

• Invasive Breast Cancer Recurrence Free Interval (IBC - RFI)

  5 years

• Disease Specific Survival (DSS)

  5 years

• Locoregional Recurrence (LRR)

  5 years

• Lymphedema Incidence

  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

  Measured at final surgical pathology (up to 21 days after surgery)

Other Outcomes (1)

• ctDNA Analysis

  ctDNA will be collected prior to start of neoadjuvant chemotherapy, day of surgery, and within 30 days of completing radiation therapy

Study Arms (1)

Axillary Surgery

EXPERIMENTAL

Procedure: Axillary Surgery

Interventions

Axillary Surgery PROCEDURE

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.

Axillary Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients stage T1-3 cN1 (prior to start of neoadjuvant chemotherapy) and pN2-3 breast cancer based on number of positive nodes on final surgical pathology.
• 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.

You may not qualify if:

• 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)
• A minimum of 1 sentinel node must be identified and excised by the surgeon. Patients who do not have an identifiable sentinel lymph node will not proceed to omission of ALND.
• Patients that have a pathologic complete response (pCR) in the breast and axilla can be considered for discussion at the Breast Multidisciplinary Tumor Conference for omission of radiation. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+).
• 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 at day of surgery in pre-operative holding prior to initiating treatment.
• 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.
• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Related Publications (28)

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• Muslumanoglu 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.

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  BACKGROUND

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Related Links

• NIH National Cancer Institute - Division of Cancer Treatment \& Diagnosis - Cancer Therapy Evaluation Program Division of Cancer Therapy and Diagnosis National Cancer Institute National Institutes of Health U.S. Department of Health and Human Services.
• European Medicines Agency. ICH E2A Clinical safety data management: definitions and standards for expedited reporting - Scientific guideline.
• Guidance for Industry - E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1).
• Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices Guidance for Industry - Draft Guidance. December 2024.
• Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur J Cancer 2009; Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jamie Wagner, D.O.

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KUCC Navigation

CONTACT

(913) 588-3671; kucc_navigation@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share