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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |