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| Sponsor: | Centre hospitalier de l'Université de Montréal (CHUM) |
|---|---|
| Collaborator: |
Fondation du cancer du sein du Québec |
| Information provided by: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT00909441 |
Purpose
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
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
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Invasive Breast Cancer |
Procedure: Sentinel Lymph Node Biopsy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer |
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Conditions for patient eligibility
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nicole Tremblay, Ph.D. | 514-890-8000 ext 15535 | nicole.g.tremblay.chum@ssss.gouv.qc.ca |
| Contact: Ana Lydia Tkalec, B.Sc. | 514-890-8000 ext 14186 | ana.lydia.tkalec.chum@ssss.gouv.qc.ca |
| Canada, Quebec | |
| Centre de recherche du Centre hospitalier de l'Université de Montréal | Recruiting |
| Montréal, Quebec, Canada, H2W 1T7 | |
| Contact: Nicole Tremblay, Ph.D. 514-890-8000 ext 15535 nicole.g.tremblay.chum@ssss.gouv.qc.ca | |
| Principal Investigator: | Jean-François Boileau, MD FRCSC | Centre Hospitalier de l'Université de Montréal |
More Information
| Responsible Party: | Jean-François Boileau, Centre de recherche du CHUM (CRCHUM) |
| ClinicalTrials.gov Identifier: | NCT00909441 History of Changes |
| Other Study ID Numbers: | CE 08.224 |
| Study First Received: | May 25, 2009 |
| Last Updated: | July 14, 2011 |
| Health Authority: | Canada: Health Canada |
|
Breast Cancer Node Positive Breast Cancer Sentinel Lymph Node Biopsy |
Breast Surgery Axillary Lymph Node Dissection Neoadjuvant Chemotherapy |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |