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van CCT (UK)

van CCT (UK)

BOOG 2013-07: The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy.

- candidate number22884
- NTR NumberNTR5495
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2015
- Secondary IDsNL44110.031.13 M14CAT
- Public TitleBOOG 2013-07: The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy.
- Scientific TitleBOOG 2013-07: The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy.
- hypothesisCompletion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy and results in a significantly lower axillary morbidity rate and an improved quality of life.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Mastectomy, Axillary lymph node dissection
- Inclusion criteria1. Female
2. Aged 18 years or older
3. Pathologically confirmed invasive unilateral breast carcinoma
4. A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
5. Will be or is treated with mastectomy
6. Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
7. SLN procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
8. pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases.
9. Written informed consent

Furthermore, neoadjuvant systemic therapy and primary and secondary breast reconstructions are also allowed.
- Exclusion criteria1. Clinically node positive pre-operative
2. Sentinel lymph nodes only containing isolated tumour cells (<0.2mm)
3. Solitary parasternal sentinel lymph node metastasis (pN1b)
4. Bilateral breast cancer
5. Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
6. Evidence of metastatic disease
7. History of invasive breast cancer
8. Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
9. Pregnant or nursing
10. 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
11. Unable or unwilling to give informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2015
- planned closingdate31-mei-2017
- Target number of participants878
- InterventionsPatients randomized for arm A will undergo completion axillary treatment. Completion axillary treatment can consist of an ALND or axillary radiotherapy in accordance to the Dutch breast cancer guideline. Axillary radiotherapy can be either level 1 and 2, or level 1, 2 and 3, including the supraclavicular nodes.

Randomization arm B (study arm): without completion axillary treatment.
- Primary outcomeRegional recurrence rate after 5- and 10 years of follow-up.
- Secondary outcomeDistant-disease free survival, overall survival, number of delayed axillary lymph node dissections, axillary morbidity rate, quality of life, local recurrence rate, contralateral breast cancer and administration of chest wall radiotherapy after 5- and 10 years of follow-up.
- Timepoints5- and 10 years.
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Pink Ribbon, KWF Kankerbestrijding, CZ, health insurance company
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, Pink Ribbon, CZ zorgverzekeringen
- Publications1. L.M. van Roozendaal, J.H.W. de Wilt, T. Van Dalen, J.A. van der Hage, L.J.A. Strobbe, L.J. Boersma, S.C. Linn, M.B.I Lobbes, P.M.P. Poortmans, V.C.G Tjan-Heijnen, K.K.B.T. van de Vijver, J. de Vries, A.H. Westenberg, A.G.H. Kessels, M.L. Smidt. The value of completion axillary treatment in sentinel node positive breast cancer patients undergonig a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07). BMC Cancer (2015) 15:610 DOI 10.1186/s12885-015-1613-2
- Brief summaryClinically T1-2N0 (tumour < 5 cm) invasive breast cancer with a limited positive sentinel lymph node, undergoing mastectomy are randomized for no no completion axillary treatment (axillary lymph node dissection or radiotherapy of the axilla) or completion axillary treatment (standard care).
- Main changes (audit trail)
- RECORD16-sep-2015 - 5-jan-2016

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