Status:
COMPLETED
Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Quebec Breast Cancer Foundation
Conditions:
Breast Cancer
Invasive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 sentine...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00909441
Start Date
February 1 2009
End Date
December 1 2012
Last Update
February 10 2015
Active Locations (1)
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1
Centre de recherche du Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2W 1T7