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Tamoxifen Study

2014-08-27 04:00:05 | BioPortfolio

Summary

To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.

Description

BACKGROUND:

Tamoxifen is nominally called an 'anti-estrogen' although it has some estrogen-agonist activities and tends to increase plasma endogenous estrogen levels. Several studies have confirmed that it decreases plasma total cholesterol and LDL-cholesterol and a review of mortality in patients taking tamoxifen as adjuvant therapy for breast cancer indicates a decreased number of vascular deaths in women on tamoxifen compared to those not on this agent.

DESIGN NARRATIVE:

Subjects were randomized to receive 10 mg of tamoxifen two times a day or to placebo. The primary endpoint was prevention of invasive breast cancer. The secondary endpoint was the effects on fatal and nonfatal cardiovascular events (coronary heart disease, stroke, and thromboembolic disease) and fractures. A total of 13,388 women at increased risk for breast cancer were randomly assigned to receive either tamoxifen (20 milligrams per day) or placebo. Cardiovascular follow-up was available for 13,194 women. The median follow-up was 57 months; the mean follow-up was 49 months. During long-term follow-up, 76 percent of the tamoxifen participants were compliant with the study therapy; 83 percent were compliant through 24 months of follow-up. To evaluate the effects of tamoxifen in women with and without pre-existing heart disease, the 13,388 women enrolled at the 131 clinical sites were divided into subgroups of those with and without a self-reported history of clinical coronary heart disease, defined as myocardial infarction or angina prior to randomization. Medical records for subjects with suspected cardiovascular events were collected by the clinical sites and forwarded to the NSABP Operations Center for adjudication by investigators who were blinded to treatment assignment. Primary cardiovascular events included fatal myocardial infarction, Q-wave myocardial infarction, and non-Q-wave myocardial infarction. Secondary cardiovascular events included unstable angina (angina requiring hospitalization) and severe angina (angina requiring revascularization). All subjects were included in the analysis using the intent-to-treat principle.

Study Design

Allocation: Randomized, Control: Placebo Control, Primary Purpose: Prevention

Conditions

Cardiovascular Diseases

Intervention

tamoxifen

Status

Completed

Source

National Heart, Lung, and Blood Institute (NHLBI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:05-0400

Clinical Trials [1433 Associated Clinical Trials listed on BioPortfolio]

Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen

Aim of work: 1. To estimate the frequency of Cyp2D6*1 and *4 alleles in Egyptian patients maintained on tamoxifen (20 mg/day) for management of ER +ve breast cancer. 2. To...

MBI Response toTam

The study will examine whether changes in background parenchymal uptake (BPU) on molecular breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have previ...

Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if ...

Zoladex Plus Tamoxifen in Breast Cancer

The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in terms of ...

An Observational Study to Assess Response to Tamoxifen

CYPTAM-BRUT 2 is a prospective, multicentric study including postmenopausal women receiving tamoxifen for metastatic, locally advanced (stage IIIB/C) or in the neoadjuvant setting for meas...

PubMed Articles [11573 Associated PubMed Articles listed on BioPortfolio]

CYP2D6 genotype and endoxifen plasma concentration do not predict hot flash severity during tamoxifen therapy.

Tamoxifen is frequently prescribed to prevent breast cancer recurrence. Tamoxifen is a prodrug and requires bioactivation by CYP2D6. Tamoxifen use is often limited by adverse effects including severe ...

Association between alexithymia and risk of incident cardiovascular diseases in the SUpplémentation en Vitamines et Minéraux AntioXydants (SU.VI.MAX) Cohort.

Although alexithymia has been suggested to be associated with cardiovascular diseases, studies are scarce and a causal relationship is questionable. This study explored the prospective association bet...

12-year trends in cardiovascular risk factors (2002-2005 through 2011-2014) in patients with cardiovascular diseases: Tehran lipid and glucose study.

To examine the trend of cardiovascular diseases (CVD) risk factors among a Middle Eastern population with prevalent CVD during a median follow up of 12 years.

Lipidomic insight into cardiovascular diseases.

Cardiovascular disease is a primary cause of mortality worldwide. Therefore, it is of major interest to identify sensitive molecular markers that predict cardiovascular events and point to therapeutic...

Introduction and Update on Obesity and Cardiovascular Diseases 2018.

Medical and Biotech [MESH] Definitions

Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

Methods and procedures for the diagnosis of diseases or dysfunction of the cardiovascular system or its organs or demonstration of their physiological processes.

Diseases of long duration and generally slow progression. The four main types of noncommunicable diseases are CARDIOVASCULAR DISEASES (e.g., heart attacks and stroke), CANCER, chronic respiratory diseases (e.g., CHRONIC OBSTRUCTIVE PULMONARY DISEASE and ASTHMA) and DIABETES MELLITUS.

Unexpected rapid natural death due to cardiovascular collapse within one hour of initial symptoms. It is usually caused by the worsening of existing heart diseases. The sudden onset of symptoms, such as CHEST PAIN and CARDIAC ARRHYTHMIAS, particularly VENTRICULAR TACHYCARDIA, can lead to the loss of consciousness and cardiac arrest followed by biological death. (from Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th ed., 2005)

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