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Search / Trial NCT00909441

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

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · May 27, 2009

Trial Information

Current as of May 02, 2025

Completed

Keywords

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

ClinConnect Summary

No description provided

Gender

FEMALE

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.

About Centre Hospitalier De L'université De Montréal (Chum)

The Centre Hospitalier de l'Université de Montréal (CHUM) is a leading academic health institution in Canada, dedicated to advancing patient care through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHUM is committed to leveraging its multidisciplinary expertise and state-of-the-art facilities to facilitate groundbreaking studies that enhance medical knowledge and improve health outcomes. Collaborating with a network of healthcare professionals and researchers, CHUM fosters a rigorous research environment that prioritizes patient safety, ethical standards, and scientific integrity, positioning itself at the forefront of medical advancements.

Locations

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Jean-François Boileau, MD FRCSC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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