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

Recruiting

• Conditions: breast neoplasms; breast cancer; axillary lymph node dessction; mastectomy.

• Registration Number: NL-OMON29048
• Lead Sponsor: Pink Ribbon, KWF, CZ

Brief Summary

1. 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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 878

Inclusion Criteria

1. Female

2. Aged 18 years or older

Exclusion Criteria

1. Clinically node positive pre-operative

2. Sentinel lymph nodes only containing isolated tumour cells (<0.2mm)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regional recurrence rate after 5- and 10 years of follow-up.

Secondary Outcome Measures

Name	Time	Method
Distant-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.