Clinical trial NCT00052676: Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer
Official title: French Randomized Sentinel Node Multicentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

Detailed description: OBJECTIVES:

* Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification.
* Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs.
* Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid.
* Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection.

Patients are followed for disease evolution.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed invasive breast cancer

  * T0, T1, or T2 no greater than 3 cm, N0
  * Amenable to surgery
* No inflammatory breast cancer
* No ductal cancer in situ or multicentric invasive ductal cancer
* No nipple/areola or central breast cancer (at least 2 cm from areola)
* No metastatic disease
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* Over 18

Sex

* Not specified

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant
* Negative pregnancy test
* No known allergy or intolerance to patent blue V dye

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No prior surgery for cancer

Other

* No prior neoadjuvant treatment for cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut J. Paoli and I. Calmettes
city: Nantes-Saint Herblain
country: France
facility: Centre Regional Rene Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Centre Paul Strauss
name: Jean-Francois Rodier, MD
role: STUDY_CHAIR
References:
citation: Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Bremond A, Classe JM, Dravet F, Routiot T, de Lara CT, Avril A, Lorimier G, Fondrinier E, Houvenaeghel G, Avigdor S. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9. doi: 10.1200/JCO.2006.08.4228. Epub 2007 May 7.