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.