Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy

Conditions

Breast Neoplasms

Brief summary

STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate. HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.

R. J. Schipper, L. M. van Roozendaal, V. M. Wintraecken, J. M. Simons, M. Moossdorff et al. (43 authors)

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10.1158/1557-3265.sabcs25-gs2-11

Three-year patient-reported outcomes of the BOOG 2013-08 RCT evaluating omission of sentinel lymph node biopsy in early-stage breast cancer patients treated with breast conserving surgery: Impact of personality traits on health-related quality of life

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Wintraecken VM, Boersma LJ, van Roozendaal LM, de Vries J, van Kuijk SMJ, Vane MLG, van Dalen T, van der Hage JA, Strobbe LJA, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, van de Vijver KKBT, Westenberg AH, de Wilt JHW, Smidt ML, Simons JM, BOOG 2013-08 group.

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Imaging Protocol and Criteria for Evaluation of Axillary Lymph Nodes in the NAUTILUS Trial

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10.4048/jbc.2021.24.e47

Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08).

van Roozendaal LM, Vane MLG, van Dalen T, van der Hage JA, Strobbe LJA, Boersma LJ, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, Van de Vijver KKBT, de Vries J, Westenberg AH, Kessels AGH, de Wilt JHW, Smidt ML.

2017-07-01120 citations

10.1186/s12885-017-3443-x

Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol.

Charaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ.

2017-03-0933 citations

10.1186/s12885-017-3144-5

Interventions

PROCEDURESentinel lymph node procedure

Sentinel lymph node procedure according to the Dutch breast cancer guideline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Female * Aged 18 years or older * Pathologically confirmed invasive breast carcinoma * A clinical T1-2 tumor * Will be treated with lumpectomy and whole breast radiotherapy * Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology) * Written informed consent

Exclusion criteria

* Clinically node positive pre-operative * Bilateral breast cancer * Evidence of metastatic disease * History of invasive breast cancer * Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi) * Pregnant or nursing * Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies \> 5 years before randomization * Unable or unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
Regional recurrence rate	Up to ten years	Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORMarjolein L Smidt, MD, PhD

Maastricht University Medical Centre, Maastricht, the Netherlands

PRINCIPAL_INVESTIGATORHans JW de Wilt, MD, PhD

Radboud University Medical Centre, Nijmegen, the Netherlands

Outcome results

None listed