Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Menopause

Antineoplastic Agents

Antihypertensive Agents

All Drugs and Chemicals

Tibolone

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Anabolic Androgenic Steroids

Anabolic Agents

Judy Garber, MD, MPH

Women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. This study will evaluate tibolone in women experiencing surgical menopause to assess its effects on bone health, menopause symptoms and breast density.

Women interested in participating in this study will be allowed to use hormones to manage symptoms for up to 3 months before beginning the study. Those choosing not to take hormones may enroll in the study immediately.

All women will have a baseline mammogram, breast examination, and bone study density performed, along with blood and urine analysis for measurement of bone markers. They will also be asked to take a questionnaire.

Patients will take either tibolone or placebo once daily for 1 year. Neither the patient or the physician will be aware of which treatment a woman is taking during the study.

Patients will return at 6 and 12 months to have a physical examination, blood work, urine collection and bone studies. At one year, a repeat mammogram will be performed. There are also some questionnaires asking about menopause symptoms that will be performed at intervals during the study.

It is also recommended that patients take calcium and vitamin D throughout the study.

Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy

A Randomized Study of the Effects of Tibolone on Bone Density, Menopause Symptoms and Breast Density in High Risk Women After Prophylactic Oophorectomy

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

United States Department of Defense

Dana-Farber Cancer Institute

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Micronutrients

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Vitamins

Vitamin D

Cholecalciferol

Celecoxib

Prostaglandin Antagonists

Trace Elements

Calcium

Calcium, Dietary

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Vitamin D3

Calciferol

In this arm, the placebo is in place of celecoxib and the current RDA for cholecalciferol is used the control of the cholecalciferol higher dose.

celecoxib 400 mg \& cholecalciferol2,000 IU

Take 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days

placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU

Edward R. Sauter, MD, PhD, M.H.A

This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.

The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.

This is a biomarker study with the goal of measuring changes in protein and rna expression. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.

66 women at normal risk for developing breast cancer will be recruited and enrolled. 22 women will be randomized into each arm, with anticipation of 2 women in each group will not be evaluable, leaving 20 in each group for evaluation.

A combination of vitamin D and celecoxib act synergistically to decrease breast cancer risk by decreasing cell proliferation in the mammary epithelium through their action on prostaglandin synthesis and metabolism.

Specific Aims:

-Evaluate vitamin D metabolism, through the measurement of CYP24 in the breast.

2-Evaluate breast specific levels of vitamin D and celecoxib, and assess if the levels of these compounds correlate with response to markers which influence prostaglandin synthesis and metabolism. Additionally, in women without active breast cancer , we will determine the effect of vitamin D, with or without celecoxib, on 1) PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast, 2) proliferative activity in the breast,, and 3) circulating levels of vitamin D and celecoxib, to determine if levels of these compounds correlate with response to markers of PG production, metabolism, or cell proliferation.

Changes in Biomarkers Using Prostaglandin Inhibitors

Prostaglandin Inhibition to Prevent Breast Cancer

This will be measured from both baseline and completion samples

1. PG synthesis and metabolism, through the measurement of 15-PGDH, COX-2, and PGE2 in the breast

Rationale: 1,25(OH)2D, the active form of vitamin D, has been shown in vitro to decrease PGE2 both by interfering with its production and by increasing its breakdown, leading to lower cell proliferation. Celecoxib potentiated the antiproliferative effect, allowing a much lower dose of each agent when used in combination than in isolation.

This will be measured from both baseline and completion samples.

2. Proliferative activity in the breast, as measured by MD cell morphology

Rationale: Both MD and NAF contain ductal epithelial cells, but MD samples contain more cells for cytologic review than NAF. Findings on MD cytology correlate with likelihood of breast cancer, NAF cytology relates to breast cancer risk and improves risk stratification, and bioactive food components can alter NAF cytology

Susan G. Komen Breast Cancer Foundation

Hartford Hospital

MD, PhD, M.H.A

women at high risk of breast cancer undergoing enhanced MRI

no intervention

shu wang, doctor

Yuan peng

Shu Wang

yuan peng, MD

Use Convolutional Neural Networks Analysis for Classification of Contrast-enhancing Lesions at Multiparametric Breast MRI. Build an abbreviated protocal, and investigate whether an abbreviated protocol was suitable for breast magnetic resonance imaging screening for breast cancer in high-risk Chinese women, which can shorten the examination time and avoid enhanced imaging while ensuring the accuracy of the diagnosis.

Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women

Peking University People's Hospital Breast Center

compare the rates of detection of breast cancers in the screening of high-risk populations between the Breast MRI full sequence, contrast-enhanced and non-contrast-enhanced sequence.

compare the sensitivity，specificity， positive predictive value and negative predictive value of breast tumor detection by radiologists and deep learning models.

Peking University People's Hospital

Director of Breast Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy	NCT00165204	Menopause Postmenopausal ... Breast Cancer	Tibolone	18 Years -	Dana-Farber Cancer Institute
Changes in Biomarkers Using Prostaglandin Inhibitors	NCT01769625	Biomarker Chang...	placebo/celecox...	18 Years -	Hartford Hospital
Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women	NCT04996615	Breast Cancer Magnetic Resona...	no intervention	-	Peking University People's Hospital
Changes in Biomarkers Using Prostaglandin Inhibitors	NCT01769625	Biomarker Chang...	placebo/celecox...	18 Years -	Hartford Hospital
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy	NCT00165204	Menopause Postmenopausal ... Breast Cancer	Tibolone	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for high risk women