Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450873
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Turkey Tail Mushroom for Treating Post-Menopausal Women with HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PRIMARY OBJECTIVE
I To determine changes in proliferation Ki-67 in ERHER2- 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
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
I To determine changes in proliferation Ki-67 in ERHER2- 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC220305 | OTHER | Mayo Clinic | None |
| NCI-2024-03999 | REGISTRY | None | None |
| 23-003846 | OTHER | None | None |