HER2-Negative Breast Carcinoma Clinical Trial
Official title:
A Phase 2 Pilot Window of Opportunity Study Turkey Tail Mushrooms (TTM) (Trametes Versicolor) in Post-Menopausal Women With HER2 (-) ER (+) Breast Cancer Planning to Undergo Surgical Therapy
This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.
PRIMARY OBJECTIVE: I. To determine changes in proliferation (Ki-67) in ER+HER2- breast cancers that receive turkey tail administration. SECONDARY OBJECTIVES: I. To assess associated adverse effects of coriolus versicolor extract (TTM). II. To determine if quality of life (QOL), mood and energy levels change while taking TTM. III. To determine if tumor pathology is affected by TTM as manifested by a change in cellularity. OUTLINE: Patients receive TTM orally (PO) once daily (QD) or twice daily (BID) starting at the time of study registration and continuing up to the day prior to standard of care (SOC) surgery (up to 3-6 weeks) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up 7-30 days after last dose. ;