Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

French Randomized Sentinel Node Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052676
• Other study ID #: STRAUSS-FRANSENOD
• Secondary ID: CDR0000258612EU-
• Status: Completed
• Phase: N/A
• First received: January 24, 2003
• Last updated: May 14, 2013
• Start date: October 2002
• Est. completion date: May 2007

Study information

• Verified date: September 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• patent blue V dye

Procedure:
• radionuclide imaging

• sentinel lymph node biopsy

Radiation:
• technetium Tc 99m sulfur colloid

Locations

Country	Name	City	State
France	Clinique Tivoli	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Leon Berard	Lyon
France	Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional Rene Gauducheau	Nantes-Saint Herblain
France	Centre Paul Strauss	Strasbourg
France	Institut Claudius Regaud	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Paul Strauss

Country where clinical trial is conducted

France, 

References & Publications (1)

Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Brémond 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 periareola — View Citation