Studieoverzicht - 2013-08 lumpectomie

 
Number 2013-08 lumpectomie
Nickname 2013-08 lumpectomie
Status Open Date: 16-04-2015
Inclusion closed
Other study number(s)
Participating parties/groups
Full title Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up.
Phase and type Randomized Phase III
Age >18
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 1644
Actual accrual 613 Date: 01-08-2018
Estimated study completion date 01-10-2020
CCMO approval Not applicable Date: Nr:
EudraCT nr. Not applicable
Trial Register
METC approval Date: METC: Nr:
Amendments Date:
KWF-CKS approval Yes Date: 20-02-2014 Nr: KWF UM 2014-6679
News item
Website https://www.kanker.nl/bibliotheek/artikelen/7308-boog-2013-08-lumpectomie-borstkanker
Sponsor Maastricht UMC+
Principal Investigator(s) M.L. Smidt, J.H.W. de Wilt
Study manager R. de Peuter (trialconsulent IKNL)
Central datamanagement and randomization IKNL Clinical Trial Centre
Tel: +31 (0)24 361 68 37
Fax: +31 (0)24 361 90 80
E-mail: trialbureau@iknl.nl
Monitoring
Local datamanagement IKNL
Funding Logo KWF.jpgFunding by KWF
Extra

Design:

A prospective non-inferiority randomized multicentre trial.


Patient group:
Women aged 18 years or older with pathologically confirmed unilateral cT1-2N0* invasive breast cancer about to undergo breast conserving surgery followed by radiotherapy of the breast.

Randomization:
Arm A - control arm: lumpectomy with sentinel lymph node procedure, followed by radiotherapy of the breast with or without completion axillary treatment according to the Dutch guideline.
Arm B - study arm: lumpectomy without further axillary staging, followed by radiotherapy of the breast.

Stratification:
Patients will be stratified by: age (≤50, 50≤75, >75 years old), oestrogen receptor status (positive vs. negative), HER2neu status (amplified vs. not amplified), clinical tumour stage prior to any treatment (<3 cm vs. ≥3 cm), grading (grade I-II vs. III - according to Bloom-Richardson grading system), primary systemic therapy and participating centre.

Objectives:


Primary objective:
The primary objective of this study is to investigate 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.

Secondary objectives:
Secondary objectives of this study are to investigate 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 distant-disease free survival, overall survival rate, the local recurrence rate and the occurrence of contralateral breast cancer.
Other secondary objectives are the influence of omitting the sentinel lymph node procedure on the number of delayed axillary lymph node dissections, the axillary morbidity rate and quality of life.

Endpoints:


Primary endpoint:
Regional recurrence rate.

Secondary endpoints:
Regional recurrence free survival, number of delayed axillary lymph node dissections, distant-disease free survival, overall survival, local recurrence rate, other-regional recurrence rate, contralateral breast cancer rate, percentage difference in the administration of postoperative radiotherapy, axillary morbidity rate, quality of life.

Main eligibility criteria:


Inclusion criteria:
1. Female
2. Aged 18 years or older
3. Pathologically confirmed invasive unilateral breast carcinoma
4. A clinical T1-2 tumour (≤ 5cm)
5. Will be treated with lumpectomy followed by whole breast radiotherapy
6. Clinically node negative (cN0): no signs of axillary lymph node metastases at physical examination and a negative preoperative axillary ultrasound (or negative cyto-/histopathology)
7. Written informed consent
Furthermore, primary systemic therapy is allowed if the patient has a clinical T1-2 tumour that is amenable to lumpectomy pre-systemic therapy.

Exclusion criteria:
1. Clinically node positive pre-operative
2. Bilateral breast cancer
3. Evidence of metastatic disease
4. History of invasive breast cancer
5. Previous treatment of the axilla by surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
6. Pregnant or nursing
7. 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 history of unsuccessfully treated malignancies
8. Unable or unwilling to give informed consent

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