Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer

Inclusion Criteria:

- Male and female subjects should be over 18 years of age and capable of providing
informed consent indicating awareness of the investigational nature of this trial, in
keeping with institutional policy

- Written informed consent must be obtained from each subject prior to entering the
study

- Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo
either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary
dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary
lymph node dissection

- Able to stay overnight in the hospital post surgery

Exclusion Criteria:

- Any subject younger than 18 years or older than 85 years of age

- History of previous breast surgery (aside from biopsy), planned breast conserving
operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap)

- American Society of Anesthesia (ASA) classification of 4 or greater, or any
contraindication to having regional anesthesia

- Any subjects who receives an intraoperative or postoperative blood transfusion during
the period of venous blood sampling

- Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing
(urine HCG) or by history (tubal ligation, hysterectomy, or menopause) is required
prior to inclusion in the study

- Subjects with active infectious process at the site of proposed paravertebral
injection

- Subjects with significant allergy to local anesthetics

- Subjects who convert from RA to GA during surgery