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Completed

NCT Number: NCT00909441

Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive 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

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche du Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2W 1T7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sentinel Lymph Node Biopsy

Procedure

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.

Primary outcomes

  1. The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.

    Time frame: 4-7 months

Secondary outcomes

  1. 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

  2. Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy

    Time frame: 4-7 months

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Quebec Breast Cancer Foundation

Registry information

Official study 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

Acronym: SN-FNAC

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 28, 2009
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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