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 non-inferior regional control, distant-…
ID
Bron
Aandoening
breast neoplasms; breast cancer; sentinel lymph node biopsy; breast conserving therapy.
Ondersteuning
CZ
ZonMw
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Regional recurrence rate after 5- and 10 years of follow-up.
Achtergrond van het onderzoek
Clinically T1-2N0 (tumour < 5 cm) invasive breast cancer about to undergo breast conserving surgery followed by radiotherapy of the breast are randomized for no sentinel lymph node procedure or sentinel lymph node procedure (standard care).
Doel van het onderzoek
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 non-inferior regional control, distant-disease free survival and overall survival.
Onderzoeksopzet
5- and 10 years.
Onderzoeksproduct en/of interventie
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.
Publiek
[default]
The Netherlands
Wetenschappelijk
[default]
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Female
2. Aged 18 years or older
3. Pathologically confirmed invasive unilateral breast carcinoma
4. A clinical T1-2 tumour
5. Will be treated with lumpectomy and whole breast radiotherapy
6. Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
7. Written informed consent
Primary systemic therapy is allowed if the patient has a clinical T1-2N0 status (initial stage) that is amenable to lumpectomy pre-systemic therapy.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 ipsilateral axilla with 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 malignancies that occurred more than five years before randomization, and 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
8. Unable or unwilling to give informed consent
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5392 |
| NTR-old | NTR5493 |
| CCMO | NL49315.031.14 |
| OMON | NL-OMON54499 |