Breast Cancer Clinical Trial
Official title:
Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of genistein may be effective in preventing
breast or endometrial cancer.
PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in
preventing breast or endometrial cancer in healthy postmenopausal women.
OBJECTIVES:
- Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting
COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.
- Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue
by oligoarray profiling in these participants.
- Determine the effect of genistein on estrogenic effects by self-reported side effects,
measurement of sex hormone-binding globulin, follicle-stimulating hormone, luteinizing
hormone, and estrogen levels, and expression of known estrogen-sensitive genes in these
participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are
stratified according to their study ID numbers. Participants are randomized to 1 of 2
treatment arms.
- Arm I: Participants receive oral genistein twice daily on days 1-84.
- Arm II: Participants receive oral placebo twice daily on days 1-84. In both arms,
treatment continues in the absence of dysplasia, malignancy, unacceptable toxicity, or
gross noncompliance.
Participants are followed at days 7, 14, 28, 56, and 84 during study treatment and at day 28
after completion of study treatment.
PROJECTED ACCRUAL: A total of 30 participants (20 for arm I and 10 for arm II) will be
accrued for this study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| 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
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| 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 |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |