Clinical Trial of Trametes Versicolor in Women With Breast Cancer

Inclusion Criteria:

Diagnosis, within the previous 12 months with Stage I-III, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
Estrogen and/or progesterone receptor-negative or positive
Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
Willing to avoid taking any product containing Trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.

Adequate organ function within 14 days of study enrollment including the following:

Adequate bone marrow reserve: White blood cells (WBC) ≥ 2,000/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL
Hepatic: Bilirubin ≤ 20% times upper limit of normal (ULN), Alkaline phosphatase ≤ 20% times ULN, AST and ALT ≤ 20% times ULN
Renal: Creatinine ≤ 20% times ULN
Nutritional status: Albumin ≥ 3.0 g/dL
Negative pregnancy test
Voluntary written consent before performance of any study-related procedure not part of the normal medical care

Exclusion Criteria:

Pregnant - Patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of Trametes versicolor.
Known allergy to fungi, including mushrooms
Serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
Receipt of hematopoietic growth factors (e.g., Neupogenâ„¢, Epogenâ„¢) within the previous 4 weeks
Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
Unwilling to discontinue excluded medications and supplements