NCT00909441

Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer

Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. Objectives of the study: Primary objective 1\. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy. Secondary objectives 1. Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy. 2. Evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients. Number of patients: N = 300 Population: Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes. Study duration: From February 2009 to February 2012 - 3 years

Conditions

• Breast Cancer
• Invasive Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Sentinel Lymph Node Biopsy	Sentinel node biopsy is a technique in which a radioactive isotope is injected in the breast, with or without blue dye. These substances will then migrate and concentrate in the first nodes in the axilla that drain the breast: The sentinel nodes. These nodes (usually one to four nodes) are then evaluated for the presence of cancer cells.

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-02-01
• Completion: 2012-12-01
• First posted: 2009-05-28
• Last updated: 2015-02-10

Locations

1 site across 1 country: Canada