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

Breast Cancer Clinical Trial

— SN-FNAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909441
• Other study ID #: CE 08.224
• Status: Completed
• Phase: N/A
• First received: May 25, 2009
• Last updated: February 9, 2015
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Invasive Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre de recherche du Centre hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Fondation du cancer du sein du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.		4-7 months	Yes
Secondary	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	No
Secondary	Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy		4-7 months	Yes