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

NCT00909441 | Completed DMC

• 1 other identifier: CE 08.224
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy.
2. 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.

Conditions

Breast Cancer; Invasive Breast Cancer

Keywords

Breast Cancer; Node Positive Breast Cancer; Sentinel Lymph Node Biopsy; Breast Surgery; Axillary Lymph Node Dissection; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.

  4-7 months

Secondary Outcomes (2)

• 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.

  3-6 months

• Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy

  4-7 months

Study Arms (1)

SNB + ALND

EXPERIMENTAL

Intervention: Sentinel Lymph Node Biopsy followed by Axillary Node Dissection.

Procedure: Sentinel Lymph Node Biopsy

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

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.

SNB + ALND

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Quebec Breast Cancer Foundation: collaborator

Study Sites (1)

Centre de recherche du Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2W 1T7, Canada

Location

Related Publications (1)

• Boileau JF, Poirier B, Basik M, Holloway CM, Gaboury L, Sideris L, Meterissian S, Arnaout A, Brackstone M, McCready DR, Karp SE, Trop I, Lisbona A, Wright FC, Younan RJ, Provencher L, Patocskai E, Omeroglu A, Robidoux A. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.

  PMID: 25452445 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Jean-François Boileau, MD FRCSC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2009
• First Posted: May 28, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 10, 2015

Record last verified: 2011-06

Locations

CA (1)