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NCT02466737 · CITED IN SOURCE DOCUMENTS

Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-05-01

Although there is no doubt that the presence of lymph node metastases worsens prognosis of a patient, unambiguous evidence to support lymph node dissection is still lacking. For many solid tumors, the role of lymph node dissection is yet controversial, and may depend on the tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast cancer is now considered as staging procedure that does not seem to influence breast cancer mortality. Women with breast cancer have benefitted greatly from a series of carefully performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA is to show that less axillary surgery is better, in that oncological outcomes are the same and less surgical intervention will result in fewer surgical complications.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Written informed consent prior to beginning breast-conserving surgery, including expected cooperation of the patients for follow-up, must be obtained and documented according to the local regulatory requirements * Histologically confirmed unilateral primary invasive carcinoma of the breast (core biopsy or open biopsy). Multifocal or multicentric tumors are allowed if breast-conserving surgery is planned * Age at diagnosis at least 18 years * Preoperative imaging techniques with estimated tumor size of \<5 cm (iT1/iT2 irrespective of hormone sensitivity or HER2 status) * Clinically and sonographically tumor-free axilla prior to core biopsy (cN0/iN0) * In cases with cN0 and iN+, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required before randomization * No clinical evidence for distant metastasis (M0) * Planned breast-conserving surgery (R0 resection) with postoperative external whole-breast irradiation (conventional fractionation or hypofractionation) Exclusion Criteria: * History of malignancy within last 5 years, except curatively treated basalioma of the skin and carcinoma in situ of the cervix * Time since core biopsy \>3 months (optimal \<1 month) * Previous and already (neoadjuvant) treated invasive breast carcinoma * Histologically non-invasive breast carcinoma * cT3/T4 or iT3/T4 tumors * pregnant or lactating patients * Planned total mastectomy (e.g. multicentric tumors ) * Planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques * Male patients
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Procedure: no axillary surgery versus SLNB
    label
    no axillary surgery
    type
    EXPERIMENTAL
  2. description
    standard arm in first randomization
    intervention Names
    1. Procedure: no axillary surgery versus SLNB
    label
    sentinel lymph node biopsy
    type
    ACTIVE_COMPARATOR
  3. intervention Names
    1. Procedure: SLNB versus completion ALND
    label
    sentinel lymph node biopsy alone
    type
    EXPERIMENTAL
  4. description
    standard arm in second randomization
    intervention Names
    1. Procedure: SLNB versus completion ALND
    label
    completion axillary lymph node dissection
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. no axillary surgery
    2. sentinel lymph node biopsy
    description
    in cases with newly diagnosed breast cancer and clinically negative axillary status
    name
    no axillary surgery versus SLNB
    type
    PROCEDURE
  2. arm Group Labels
    1. completion axillary lymph node dissection
    2. sentinel lymph node biopsy alone
    description
    in cases with 1-3 macrometastases in sentinel lymph nodes
    name
    SLNB versus completion ALND
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
primary Purpose
TREATMENT
Enrollment
count
5505
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    non-inferiority question
    measure
    invasive disease-free survival (IDFS) after breast-conserving surgery
    time Frame
    5 years
Full study description
brief Summary
Although there is no doubt that the presence of lymph node metastases worsens prognosis of a patient, unambiguous evidence to support lymph node dissection is still lacking. For many solid tumors, the role of lymph node dissection is yet controversial, and may depend on the tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast cancer is now considered as staging procedure that does not seem to influence breast cancer mortality. Women with breast cancer have benefitted greatly from a series of carefully performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA is to show that less axillary surgery is better, in that oncological outcomes are the same and less surgical intervention will result in fewer surgical complications.
detailed Description
Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on this, the postsurgical therapy should be considered on the basis of biologic tumor characteristics rather than nodal involvement. The goal of the present study is to show that early-stage breast cancer patients with reduced extent of axillary surgery are not inferior regarding disease-free survival outcome compared with the standard arm. All patients will be first randomized to either no axillary surgical intervention or axillary sentinel lymph node biopsy (SLNB). Patients with SLNB and pN+(sn) status will be secondly randomized to either SLNB alone or completion axillary lymph node dissection (ALND) in cases with less than four involved nodes (1-3 macrometastases). Patients with four or more metastatic sentinel lymph nodes should undergo completion ALND. Postoperative systemic treatment should be based on local multidisciplinary tumor board recommendation according to the current German AGO and S3 guidelines. For women who are treated with breast-conserving surgery, the most common site of local recurrence is the conserved ipsilateral breast itself. Thus, whole-breast radiation therapy after breast-conserving surgery is mandatory and should be performed according to the current guidelines (S3, AGO, DEGRO). During follow-up, patients will be assessed for disease recurrence according to standard clinical practice. History and physical examination will be performed every 6 months for the first 36 months and yearly thereafter. Annual mammography and sonography will be required; other testing will be based on symptoms and investigator preference. The total number of patients to be randomized into the trial will be approximately 7,095. An event-driven final efficacy analysis will be performed per-protocol for two primary objectives.
Source references
references
  1. citation
    Reimer T, Stachs A, Nekljudova V, Loibl S, Hartmann S, Wolter K, Hildebrandt G, Gerber B. Restricted Axillary Staging in Clinically and Sonographically Node-Negative Early Invasive Breast Cancer (c/iT1-2) in the Context of Breast Conserving Therapy: First Results Following Commencement of the Intergroup-Sentinel-Mamma (INSEMA) Trial. Geburtshilfe Frauenheilkd. 2017 Feb;77(2):149-157. doi: 10.1055/s-0042-122853.
    pmid
    28331237
    type
    RESULT
  2. citation
    Hildebrandt G, Stachs A, Gerber B, Potenberg J, Krug D, Wolter K, Kuhn T, Zierhut D, Sedlmayer F, Kaiser J, Reitsamer R, Heil J, Nekljudova V, Bekes I, Loibl S, Reimer T. Central Review of Radiation Therapy Planning Among Patients with Breast-Conserving Surgery: Results from a Quality Assurance Process Integrated into the INSEMA Trial. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):683-693. doi: 10.1016/j.ijrobp.2020.04.042. Epub 2020 May 11.
    pmid
    32437921
    type
    RESULT
  3. citation
    Reimer T, Stachs A, Veselinovic K, Polata S, Muller T, Kuhn T, Heil J, Ataseven B, Reitsamer R, Hildebrandt G, Knauer M, Golatta M, Stefek A, Zahm DM, Thill M, Nekljudova V, Krug D, Loibl S, Gerber B; INSEMA investigators. Patient-reported outcomes for the Intergroup Sentinel Mamma study (INSEMA): A randomised trial with persistent impact of axillary surgery on arm and breast symptoms in patients with early breast cancer. EClinicalMedicine. 2022 Nov 25;55:101756. doi: 10.1016/j.eclinm.2022.101756. eCollection 2023 Jan.
    pmid
    36457648
    type
    RESULT
  4. citation
    Marme F, Krieghoff-Henning E, Gerber B, Schmitt M, Zahm DM, Bauerschlag D, Forstbauer H, Hildebrandt G, Ataseven B, Brodkorb T, Denkert C, Stachs A, Krug D, Heil J, Golatta M, Kuhn T, Nekljudova V, Gaiser T, Schonmehl R, Brochhausen C, Loibl S, Reimer T, Brinker TJ. Deep learning to predict breast cancer sentinel lymph node status on INSEMA histological images. Eur J Cancer. 2023 Dec;195:113390. doi: 10.1016/j.ejca.2023.113390. Epub 2023 Oct 18.
    pmid
    37890350
    type
    RESULT
  5. citation
    Reimer T, Stachs A, Veselinovic K, Kuhn T, Heil J, Polata S, Marme F, Muller T, Hildebrandt G, Krug D, Ataseven B, Reitsamer R, Ruth S, Denkert C, Bekes I, Zahm DM, Thill M, Golatta M, Holtschmidt J, Knauer M, Nekljudova V, Loibl S, Gerber B. Axillary Surgery in Breast Cancer - Primary Results of the INSEMA Trial. N Engl J Med. 2025 Mar 13;392(11):1051-1064. doi: 10.1056/NEJMoa2412063. Epub 2024 Dec 12.
    pmid
    39665649
    type
    RESULT
  6. citation
    Reimer T, Stachs A, Veselinovic K, Kuehn T, Heil J, Polata S, Marme F, Trapp E, Hildebrandt G, Krug D, Ataseven B, Reitsamer R, Ruth S, Denkert C, Bekes I, Stahl N, Thill M, Strittmatter HJ, Mueller T, Golatta M, Zahm DM, Holtschmidt J, Knauer M, Nekljudova V, Loibl S, Gerber B. Axillary surgery in patients with sentinel node macrometastases: secondary results of the randomized INSEMA trial. NPJ Breast Cancer. 2026 Jan 27;12(1):19. doi: 10.1038/s41523-026-00902-7.
    pmid
    41593108
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        metastases (2.0%), and 18 deaths (2.6%) in the no-surgery group. </li></ul></div></li><li>The multicenter, noninferiority, randomized <a href="/clinicaltrials/NCT02466737">INSEMA</a> trial (NCT02466737) evaluated omitting SLN biopsy in 5,502 women with clinically node-negative invasive breast cancer. Tumors had to be smaller tha
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        hs (2.6%) in the no-surgery group. </li></ul></div></li><li>The multicenter, noninferiority, randomized <a href="/clinicaltrials/NCT02466737">INSEMA</a> trial (NCT02466737) evaluated omitting SLN biopsy in 5,502 women with clinically node-negative invasive breast cancer. Tumors had to be smaller than 5 cm, and most patients had T
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      source update dates
      1. context
        Updated: April 25, 2025
        datetime
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        display
        April 25, 2025

    Preserved source evidence · Not medical advice