Estrogen Receptor-Positive Breast CarcinomaPhase 2NCT06450873
Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
A Phase 2 study testing Coriolus Versicolor Extract and Questionnaire Administration in people with Estrogen Receptor-Positive Breast Carcinoma and HER2-Negative Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
- What is being tested?
- Coriolus Versicolor Extract and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 18 years of age
- Histological confirmation of ER+, HER2- breast cancer, newly diagnosed and tissue available for central confirmation of Ki-67 measurement. Subjects are eligible if they have a Ki-67 of ≥10%. Ki-67 will be repeated for patients who have had this done externally.
- Scheduled for definitive breast surgery
- Detectable disease as defined by mammography, breast ultrasound of greater than 5mm in size.
- NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible
- Post menopausal as defined by:
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- Self-reported last menstrual period greater than 12 months, or
- Bilateral oophorectomy, or
- Follicle stimulating hormone (FSH) >20 mIU/mL, and estradiol level ≤ 20 pg/mL
- Not taking aromatase inhibitor or a selective estrogen receptor modifier
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 obtained ≤ 90 days prior to registration
- Platelet count ≥ 100,000/mm^3 (obtained ≤ 90 days prior to registration)
- Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (obtained ≤ 90 days prior to registration)
- Hemoglobin ≥ 11 g/dL (obtained ≤ 90 days prior to registration)
- Serum transaminase [alanine aminotransferase (ALT) or aspartate aminotransferase (AST)] ≤ 1.2 x upper limit of normal (ULN) (obtained ≤ 90 days prior to registration)
- Alkaline phosphatase ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)
- Serum creatinine ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)
- Provide written informed consent
- Ability to complete the Symptom Experience Diary by themselves or with assistance
Who cannot join
- Ki-67 of <10%
- Current use of any medicinal mushrooms
- Patient with locally advanced cancer who will require neoadjuvant therapy or metastatic cancer
- Currently on systemic chemotherapy
- Concurrent endocrine therapy (selective estrogen receptor modifiers or aromatase inhibitors)
- Allergy to mushrooms
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- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients
- Patients known to be HIV positive and currently receiving antiretroviral therapy.
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy 3 years prior to registration
- EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
- NOTE: If there is a history of prior malignancy, they must not be receiving chemotherapy treatment for their cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Center Clinical Trials contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Cancer Center Clinical Trials, 507-293-6386
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine changes in proliferation (Ki-67) in ER+HER2- breast cancers that receive turkey tail administration.
SECONDARY OBJECTIVES:
- 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) 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 20-42 days) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up 7-30 days after last dose.
- Being tested
- Coriolus Versicolor Extract, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coriolus Versicolor ExtractDrug
Also called Turkey Tail Mushroom Extract, Yunzhi Extract
Dietary Supplement Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TTM) | Experimental | Patients receive TTM PO BID starting at the time of study registration and continuing up to the day prior to SOC surgery (up to 20-42 days) in the absence of disease progression or unacceptable toxicity. Receives: Drug: Coriolus Versicolor Extract; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ki-67
Change in Ki-67 from the time of enrollment (pre-treatment) to the time of surgery (post-treatment) will be recorded. Slides from the original biopsy at the time of diagnosis will be used to assess pre-treatment Ki-67. A tissue sample obtained at the time of surgery will be used to assess Ki-67 post-treatment.
Measured: Baseline; at the time of surgery
Secondary outcomes (3)
Quality of life changes
Changes in quality of life will be assessed using the Symptom Experience Diary, which will be completed by study staff during weekly phone calls with participants. The Symptom Experience Diary consists of 2 yes/no questions and 10 questions answered on a scale of 0-10 where 0=none at all and 10=as bad as it can be.
Measured: Up to 10 weeks
Adverse effects of Turkey Tail Mushrooms (TTM)
Adverse effects of TTM will be assessed by the number of patients with grade 2 or higher toxicities.
Measured: Up to 10 weeks
Patient-reported outcomes
Patient reported outcomes will be assessed using the Symptom Experience Diary, which will be completed by study staff during weekly phone calls with participants. The Symptom Experience Diary consists of 2 yes/no questions and 10 questions answered on a scale of 0-10 where 0=none at all and 10=as bad as it can be.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start25 Oct 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor-Positive Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda J. Ernst, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450873
- Sponsor's protocol ID
- MC220305
- Other IDs
- 23-003846
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06450873
- Acronym / sponsor ID
- MC220305
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine changes in proliferation (Ki-67) in ER+HER2- breast cancers that receive turkey tail administration.
SECONDARY OBJECTIVES:
- 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) 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 20-42 days) 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TTM) | Experimental | Drug: Coriolus Versicolor Extract, Other: Questionnaire AdministrationPatients receive TTM PO BID starting at the time of study registration and continuing up to the day prior to SOC surgery (up to 20-42 days) in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Women ≥ 18 years of age
- Histological confirmation of ER+, HER2- breast cancer, newly diagnosed and tissue available for central confirmation of Ki-67 measurement. Subjects are eligible if they have a Ki-67 of ≥10%. Ki-67 will be repeated for patients who have had this done externally.
- Scheduled for definitive breast surgery
- Detectable disease as defined by mammography, breast ultrasound of greater than 5mm in size.
- Post menopausal as defined by:
Key exclusion criteria (20 listed)
- Ki-67 of <10%
- Current use of any medicinal mushrooms
- Patient with locally advanced cancer who will require neoadjuvant therapy or metastatic cancer
- Currently on systemic chemotherapy
- Concurrent endocrine therapy (selective estrogen receptor modifiers or aromatase inhibitors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coriolus Versicolor ExtractAlso: Turkey Tail Mushroom Extract, Yunzhi ExtractDietary Supplement Given PO | Drug | Treatment (TTM) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (TTM) |
Primary outcome
Change in Ki-67
Time frame: Baseline; at the time of surgery
Change in Ki-67 from the time of enrollment (pre-treatment) to the time of surgery (post-treatment) will be recorded. Slides from the original biopsy at the time of diagnosis will be used to assess pre-treatment Ki-67. A tissue sample obtained at the time of surgery will be used to assess Ki-67 post-treatment.
3 secondary outcomes
Quality of life changes
Time frame: Up to 10 weeks
Adverse effects of Turkey Tail Mushrooms (TTM)
Time frame: Up to 10 weeks
Patient-reported outcomes
Time frame: Up to 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Center Clinical Trials contact
Brenda J. Ernst, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coriolus Versicolor Extract and Questionnaire Administration in people with Estrogen Receptor-Positive Breast Carcinoma and HER2-Negative Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ki-67 (time frame: Baseline; at the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.