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Clinical Trials/NL-OMON54499
NL-OMON54499
Completed
Phase 3

Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up. A Dutch randomized controlled multicentre trial. - BOOG 2013-08

Medisch Universitair Ziekenhuis Maastricht0 sites1,730 target enrollmentTBD
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Conditionsbreast cancersentinel lymph node metastasessentinel lymph nodes1000629110006295

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
breast cancer
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
1730
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility Criteria

Inclusion Criteria

  • •\- Aged 18 years or older
  • •\- Pathologically confirmed invasive unilateral breast carcinoma
  • •\- A clinical T1\-2 tumour (\<\= 5cm)
  • •\- Will be treated with lumpectomy followed by whole breast radiotherapy
  • •\- Clinically node negative status: no signs of axillary lymph node metastases
  • •at physical examination and preoperative axillary ultrasound (or negative
  • •cyto\-/histopathology)
  • •\- Written informed consent

Exclusion Criteria

  • •\- Clinically node positive pre\-operative
  • •\- Bilateral breast cancer
  • •\- Evidence of metastatic disease
  • •\- History of invasive breast cancer
  • •\- 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
  • •\- Pregnant or nursing
  • •\- Other prior malignancies within the past 5 years, except successfully treated
  • •malignancies that occurred more than five years before randomization, and

Outcomes

Primary Outcomes

Not specified

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