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Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer (GATA)

I

Institut Cancerologie de l'Ouest

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: sentinel node
Procedure: GAS

Study type

Interventional

Funder types

Other

Identifiers

NCT00293865
BRD 05/11-M

Details and patient eligibility

About

The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.

Enrollment

203 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years
  • Previous conservative surgical biopsy
  • Secondary pathological diagnosis of infiltrative cancer
  • No clinically involved axillary node (N0)
  • No previous neoadjuvant treatment
  • Performance status European Cancer Conference (ECCO) Grade ≤ 1
  • Patient's written informed consent to participate in the study according to French law
  • Surgeon must have performed its learning curve

Exclusion criteria

  • Lack of infiltrative breast carcinoma (in situ) pT4d > N0
  • Breast cancer relapse
  • Pregnancy
  • Known patent blue allergy
  • Indication for radical or partial mastectomy
  • Patient unable to understand the trial

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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