Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer (SN-FNAC)
This study is currently recruiting participants.
Verified June 2011 by Centre hospitalier de l'Université de Montréal (CHUM)
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
First received: May 25, 2009
Last updated: July 14, 2011
Last verified: June 2011
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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
- Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy.
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Invasive Breast Cancer |
Procedure: Sentinel Lymph Node Biopsy |
Phase 2 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):
Primary Outcome Measures:
- The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 4-7 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluate the accuracy of clinical evaluation and ultrasound examination in determining the presence of residual disease following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
- Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy [ Time Frame: 4-7 months ] [ Designated as safety issue: Yes ]
| 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) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Conditions for patient eligibility
Inclusion criteria:
- Patients must be female.
- Patients must be 18 years of age or older.
- Patients with stage IIA, IIB, IIIA (T1-3 and N1-2) breast cancer. Clinical N0 accepted if biopsy proven node disease.
- Patients that have biopsy proven positive axillary disease made by core needle biopsy or fine needle aspiration .
- Patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until the day of surgery.
- Patients with bilateral breast cancer are eligible. Sentinel node biopsy is allowed on the contralateral breast if there is no disease in the axilla prior to chemotherapy.
- Patients that understand, accept and have signed the approved consent form.
Exclusion Criteria:
- Patients with inflammatory breast cancer.
- Patient with stage IIIB, IIIC or IV breast cancer (T4 and N3) Patients with clinical N3 disease are excluded.
- Patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible).
- Patients that have had previous radiotherapy to the axillary nodes
- Patients that have had mammary reduction
- Patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician.
- If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, Patent blue or methylene blue or radiocolloid dye are ineligible.
- Patients who are pregnant or breast feeding .
- Psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909441
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Fondation du cancer du sein du Québec
Investigators
| Principal Investigator: | Jean-François Boileau, MD FRCSC | Centre Hospitalier de l'Université de Montréal |
More Information
No publications provided
| 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 |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
Breast Cancer Node Positive Breast Cancer Sentinel Lymph Node Biopsy |
Breast Surgery Axillary Lymph Node Dissection Neoadjuvant Chemotherapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013