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

Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293865

Acronym

GATA

Enrollment

203

Registered

2006-02-20

Start date

2006-03-31

Completion date

2012-03-31

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast infiltrative cancer

Brief summary

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.

Interventions

PROCEDUREsentinel node

detection of the sentinel node in breast cancer

PROCEDUREGAS

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
false negatives	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026