search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up (BOOG 2013-08).


- candidate number22918
- NTR NumberNTR5429
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2015
- Secondary IDsNL49315.031.1 M14CAT NCT02271828
- Public TitleClinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up (BOOG 2013-08).
- Scientific TitleClinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up (BOOG 2013-08).
- ACRONYM
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Sentinel node biopsy
- Inclusion criteria1. 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.
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-mei-2015
- planned closingdate18-mei-2027
- Target number of participants1644
- InterventionsArm 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.
- Primary outcomeRegional recurrence rate after 5- and 10 years of follow-up.
- Secondary outcomeDistant-disease free survival, overall survival, delayed axillary lymph node dissections, axillary morbidity, quality of life, local recurrence, contralateral breast cancer, and percentage difference in administered (neo)adjuvant systemic therapy after 5- and 10 years of follow-up.
- Timepoints5- and 10 years.
- Trial web sitewww.boogstudycenter.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD M.L.G. Vane
- CONTACT for SCIENTIFIC QUERIESMD M.L.G. Vane
- Sponsor/Initiator KWF Kankerbestrijding, CZ, health insurance company, ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, CZ zorgverzekeringen, ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBreast cancer patients with clinically T1-2 (tumor < 5 cm) and no evidence for axillary lymph node metastasis through physical examination and ultrasound of the axilla, treated with breast conserving therapy are randomized to no sentinel lymph node procedure or sentinel lymph node procedure.
- Main changes (audit trail)
- RECORD30-sep-2015 - 11-nov-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl