Clinical Trial of Trametes Versicolor in Women With Breast Cancer

OBJECTIVES:

Primary

- To determine the maximum tolerated dose of oral coriolus versicolor extract in women
with stage I-III, estrogen receptor- and/or progesterone receptor-negative or positive
(as of 1/26/2009), infiltrating ductal adenocarcinoma of the breast who have recently
completed standard post-surgery radiotherapy.

Secondary

- To determine the feasibility of measuring changes in fatigue and quality of life of
patients treated with this drug.

- To characterize the toxicity of this drug in these patients.

- To gather preliminary data that compare baseline and post-treatment immunologic
measures, including differential blood counts (i.e., WBC), natural killer cell activity,
phagocytic index, regulatory cell assay, T/B/NK cell population subset assays,
peripheral blood mononuclear cell production of levels of interferon gamma, and tumor
necrosis factor-alpha in these patients.

OUTLINE: Patients receive oral coriolus versicolor extract twice daily for 6 weeks.

Patients undergo quality of life and fatigue assessment at baseline, weekly during study, and
at the 3-week follow-up visit.

Blood samples are collected periodically for immunological marker studies. Samples are
analyzed for T-regulatory cell, T-and B-lymphocyte, and NK cell activity in peripheral blood
mononuclear cells (PBMC), phagocytic index in monocytes and granulocytes, and cytokine
secretion and upregulation by flow cytometry, cytotoxicity assays, cytolysis assays,
T-regulatory cell assay, or T/B/NK cell population subset assays. Changes in the production
of tumor necrosis factor-alpha and interferon-gamma in serum and in supernatants of PBMCs are
analyzed via standard enzyme-linked immunosorbent assay.

After completion of study treatment, patients are followed at 3 weeks.

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., Neupogen™, Epogen™) 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