Breast Cancer Clinical Trial
Official title:
A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors
RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer
in postmenopausal breast cancer survivors.
PURPOSE: This phase I trial is studying the side effects and best dose of white button
mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who
are breast cancer survivors.
OBJECTIVES:
Primary
- To show that a whole food extract of white button mushrooms (WBM) can inhibit
aromatase-induced estrogen biosynthesis in postmenopausal women who are breast cancer
survivors (BCS).
- To determine the optimal daily dose of WBM needed to induce aromatase inhibition of
estrogen biosynthesis in these patients.
- To determine the bioavailability of C-18 unsaturated fatty acids, which are thought to
moderate the anticancer effects of WBM.
Secondary
- To determine the safety and tolerability of WBM in humans via serial comprehensive
symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre-
and post-treatment comprehensive lipid panels.
- To explore potential alternate antitumor mechanisms, specifically the effect of WBM on
cytokines as well as innate and adaptive cellular immunity.
- To describe barriers experienced in recruitment of ethnically diverse subjects from the
community into a secondary prevention BCS trial utilizing a dietary supplement
intervention in an effort to enhance feasibility of a subsequent phase II trial.
OUTLINE: This is a dose-escalation study.
Patients receive oral white button mushroom extract twice daily for 12 weeks in the absence
of a second primary ductal carcinoma in situ, invasive breast cancer, or unacceptable
toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during
treatment for pharmacokinetic, pharmacodynamic, and immunologic correlative studies. Blood
and urine samples are analyzed for concentrations of C-18 unsaturated fatty acids (CUFA) by
high-performance liquid chromatography tandem-mass spectrometry. Blood samples are also
analyzed for anti-aromatase activity by ex vivo plasma aromatase inhibition assays;
circulating sex steroid hormones by radioimmunoassay; serum immune cytokine levels by
multiplex cytokine analyses; immunophenotyping, NK-cell activation status, and NK-cell
function by multiparameter flow cytometry; lipid levels by lipid assays; and biochemical
markers of bone metabolism by bone metabolism marker assays. DNA, RNA, and plasma samples
are stored for post-trial pharmacogenomic studies.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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