Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer (SN-FNAC)

This study has been completed.
Sponsor:
Collaborator:
Fondation du cancer du sein du Québec
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00909441
First received: May 25, 2009
Last updated: February 9, 2015
Last verified: June 2011
  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

  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


Condition Intervention
Breast Cancer
Invasive Breast Cancer
Procedure: Sentinel Lymph Node Biopsy

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 ]

Enrollment: 153
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SNB + ALND
Intervention: Sentinel Lymph Node Biopsy followed by Axillary Node Dissection.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909441

Locations
Canada, Quebec
Centre de recherche du Centre hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2W 1T7
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 by Centre hospitalier de l'Université de Montréal (CHUM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00909441     History of Changes
Other Study ID Numbers: CE 08.224
Study First Received: May 25, 2009
Last Updated: February 9, 2015
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on March 26, 2015