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

Brief Summary

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”

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

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: February 2012

Interventions Used in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
    • Time Frame: 4-7 months
      Safety Issue?: Yes

Secondary Measures

  • 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.
    • Time Frame: 3-6 months
      Safety Issue?: No
  • Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy
    • Time Frame: 4-7 months
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Centre hospitalier de l’Université de Montréal (CHUM)
  • Collaborator
    • Fondation du cancer du sein du Québec
  • Provider of Information About this Clinical Study
    • Jean-François Boileau, Centre de recherche du CHUM (CRCHUM)
  • Overall Official(s)
    • Jean-François Boileau, MD FRCSC, Principal Investigator, Centre Hospitalier de l’Université de Montréal
  • Overall Contact(s)
    • Nicole Tremblay, Ph.D., 514-890-8000, nicole.g.tremblay.chum@ssss.gouv.qc.ca

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00909441