A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer

Inclusion Criteria:

* Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging
* Surgical patients undergoing lumpectomy, subtotal or total mastectomy
* 18 years of age or greater
* female
* available tissue blocks from diagnostic biopsy
* negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal
* must be willing to forego surgery for minimum of 5 days
* ability and willingness to sign written consent
* if hypertensive, on stable dose of medication at least 30 days
* if diabetic, well controlled (HbA1C \< 8.5 within past 60 days or documented FPG \< 140 mg/dl for 3 consecutive days
* ECOG status \< 2 or Karnofsky of 60% or greater

Exclusion Criteria:

* previous or current malignancy, excluding non-melanomic skin cancer
* evidence of distant metastatic disease
* history of chemotherapy, biologic or radiotherapy with 6 months of biopsy
* usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug
* history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG
* history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications
* active bleeding or a pathological condition that carries a high risk of bleeding
* any swallowing dysfunction
* uncontrolled intercurrent illness
* poorly controlled diabetes (control indicated with HbA1c \< 8.5 within past 60 days or documented fasting blood glucose \< 140 mg/dl for three consecutive days)
* known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.
* uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHG)
* pregnant or breast feeding women Women must be willing to use birth control throughout study duration.
* current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy
* current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy
* current monoamine oxidase inhibitors treatment