Clinical trial NCT00909441: Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Quebec Breast Cancer Foundation
First posted: 2009-05-28
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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


Eligibility 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.

Primary outcomes:
measure: The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
timeFrame: 4-7 months
Secondary outcomes:
measure: 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.
timeFrame: 3-6 months
measure: Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy
timeFrame: 4-7 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre de recherche du Centre hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Jean-François Boileau, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.