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Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Invasive Breast Cancer

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Trial Information

Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

4-7 months

Safety Issue:

Yes

Principal Investigator

Jean-François Boileau, MD FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier de l'Université de Montréal

Authority:

Canada: Health Canada

Study ID:

CE 08.224

NCT ID:

NCT00909441

Start Date:

February 2009

Completion Date:

February 2012

Related Keywords:

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

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