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PRIMARY OBJECTIVES:. I. To determine the impact of a two-year course of low-dose tamoxifen (tamoxifen citrate) administered at 5 mg per day on surrogate endpoint biomarkers of breast cancer (BC) risk, including: mammographic breast density (MBD), an established radiographic biomarker of BC risk; cytomorphology and proliferative index, tissue biomarkers closely linked to BC risk; and sex steroid hormones and insulin growth factors, circulating biomarkers of BC risk.. II. To establish safety and tolerability of this low-dose tamoxifen regimen, assessing both objective measures (lipid profiles, clotting factors and bone metabolism markers) and patient-reported outcomes.. III. To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year low dose tamoxifen intervention.. IV. To explore the relationship between this low-dose tamoxifen regimen and clinical measures of efficacy (new breast cancer and ductal carcinoma in situ [DCIS] ...
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Background The cytochrome P450 (CYP) enzymes 2C19, 2D6, and 3A5 are responsible for converting the selective estrogen receptor modulator (SERM), tamoxifen to its active metabolites 4-hydroxy-tamoxifen (4OHtam) and 4-hydroxy-N-demethyltamoxifen (4OHNDtam, endoxifen). Inter-individual variations of the activity of these enzymes due to polymorphisms may be predictors of outcome of breast cancer patients during tamoxifen treatment. Since tamoxifen and estrogens are both partly metabolized by these enzymes we hypothesize that a correlation between serum tamoxifen and estrogen levels exists, which in turn may interact with tamoxifen on treatment outcome. Here we examined relationships between the serum levels of tamoxifen, estrogens, follicle-stimulating hormone (FSH), and also determined the genotypes of CYP2C19, 2D6, 3A5, and SULT1A1 in 90 postmenopausal breast cancer patients. Methods Tamoxifen and its metabolites were measured by liquid chromatography-tandem mass spectrometry. Estrogen and FSH ...
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N-desmethyltamoxifen, resulting from the CYP3A4/5- mediated catalysis of tamoxifen, is the major primary quantitative metabolite of tamoxifen and accounts for approximately 92% of primary tamoxifen oxidation. N- Tamoxifen has both estrogenic and antiestrogenic desmethyltamoxifen has weak antiestrogenic effects activity, depending on the target organ. These differ- similar to tamoxifen.(48) Using N-desmethyltamoxifen ential effects lead to clinical benefits as well as to side as an intermediary substrate, it is biotransformed to α- effects and, rarely, severe toxicity.(9) Tamoxifen is anti- hydroxy-N-desmethyltamoxifen and N-didesmethyl- estrogenic in the breast as well as in the brain, resulting tamoxifen by CYP3A5 as well as 4-hydroxy-N-desmethyl- in decreased breast cancer development and recurrence, but leading to hot flashes. In contrast, tamoxifen is estro- Jordan et al.(49,50) demonstrated that hepatic metab- genic in the bone, liver, and uterus, resulting in improve- olism of tamoxifen ...
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Tamoxifen remains a widely used hormone therapy for pre and postmenopausal women with hormone receptor positive breast cancer in both adjuvant and metastatic disease settings. Resistance to this well tolerated and cost-effective drug limits its use. Only an improved understanding of the mechanisms of tamoxifen resistance will provide the basis for overcoming this phenomenon. Expression profiles from tamoxifen-resistant and sensitive MCF7 derived breast cancer cell lines were prepared, using Affymetrix HG_U133A cDNA microarrays. The data generated was analysed to identify novel pathways and genes associated with tamoxifen resistance or sensitivity. Selected genes, whose expression correlates with response to tamoxifen, were validated using RT-PCR in cell lines and following this, in situ hybridisation and immunohistochemistry on cell lines. Functional analyses of these genes were carried out: genes that were down-regulated in tamoxifen resistant MCF7 cells (HRASLS3, CTSD, CAXII) were selectively ...
Although the androgen receptor (AR) is a known clinical target in prostate cancer, little is known about its possible role in breast cancer. We have investigated the role of AR expression in human breast cancer in response to treatment with the antiestrogen tamoxifen. Resistance to tamoxifen is a major problem in treating women with breast cancer. By gene expression profiling, we found elevated AR and reduced estrogen receptor (ER) α mRNA in tamoxifen-resistant tumors. Exogenous overexpression of AR rendered ERα-positive MCF-7 breast cancer cells resistant to the growth-inhibitory effects of tamoxifen in anchorage-independent growth assays and in xenograft studies in athymic nude mice. AR-overexpressing cells remained sensitive to growth stimulation with dihydrotestosterone. Treatment with the AR antagonist Casodex™ (bicalutamide) reversed this resistance, demonstrating the involvement of AR signaling in tamoxifen resistance. In AR-overexpressing cells, tamoxifen induced transcriptional ...
BACKGROUND: The aromatase inhibitor letrozole is a more effective treatment for metastatic breast cancer and more effective in the neoadjuvant setting than tamoxifen. We compared letrozole with tamoxifen as adjuvant treatment for steroid-hormone-receptor-positive breast cancer in postmenopausal women. METHODS: The Breast International Group (BIG) 1-98 study is a randomized, phase 3, double-blind trial that compared five years of treatment with various adjuvant endocrine therapy regimens in postmenopausal women with hormone-receptor-positive breast cancer: letrozole, letrozole followed by tamoxifen, tamoxifen, and tamoxifen followed by letrozole. This analysis compares the two groups assigned to receive letrozole initially with the two groups assigned to receive tamoxifen initially; events and follow-up in the sequential-treatment groups were included up to the time that treatments were switched. RESULTS: A total of 8010 women with data that could be assessed were enrolled, 4003 in the letrozole ...
By targeting the estrogen receptors with the selective estrogen receptor modulators tamoxifen and 4-hydroxy-tamoxifen, prions could be cleared from prion-infected cell culture. Tamoxifen and 4-hydroxy-tamoxifen had half-maximal inhibitory concentrations for clearance of prions of 0.47 μM and 0.14 nM, respectively. This work identifies further factors involved in the prion disease process, and through antagonism of the estrogen system, we demonstrate that the estrogen system is a target for controlling prion levels." ... Note that, "Estrogen therapy has been shown to lower the risk of development of Alzheimers disease; however, in aged rat models, estrogen treatment postneurodegeneration worsened the degeneration process. With this in mind, estrogen application post-prion infection, particularly in an aged rat model, may have a negative impact on the disease process. This is a significant consideration for late-onset prion diseases, especially if the response of the human estrogen receptors ...
OUTLINE: This is a multicenter study.. Patients receive oral tamoxifen citrate and concurrent selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) therapy comprising oral venlafaxine, citalopram hydrobromide, escitalopram oxalate, sertraline hydrochloride, or gabapentin for 8-24 weeks. Treatment continues in the absence of disease progression.. Blood samples are obtained at baseline and after completion of study therapy. Samples are evaluated by pharmacokinetic analysis to determine the effects of SSRI/SNRI study drugs on plasma concentrations of tamoxifen and its metabolites. Plasma levels of tamoxifen citrate, N-desmethyl tamoxifen, 4-OH tamoxifen, and endoxifen are measured using reverse phase high performance liquid chromatography. Blood samples are also analyzed by CYP2D6 genotyping to test for CYP2D6 gene variation (i.e., *3, *4, *6, *10, *17, and *41) in genes that encode tamoxifen-metabolizing enzymes. Additional CYP2D6 alleles, including gene ...
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Everyone can be a candidate of having cancer. In fact, according to medical experts, all humans produce cancer cells everyday and it is actually up to the immune system to eliminate those malignant cells. However if the immune system fails to do its function this is where the cancer cells grow and develop into a tumor. For now there are no drugs that can completely cure cancer although a lot of cancer patients have higher rates of survival when taking drugs in combination with surgery and chemotherapy. To fight breast cancer, the drug tamoxifen citrate is generally what the doctors would recommend their patients to take.. Women are generally at higher risk of getting breast cancer as compared to men. Most breast cancers in women are estrogen fed; meaning breast tumors are encouraged to grow and develop once they get In contact with the estrogen hormone. Unfortunately this hormone is very abundant among women. Second thing is that women with family histories of breast cancer are likely inclined ...
AT ACOG 2017. SAN DIEGO (FRONTLINE MEDICAL NEWS) - Continuation of tamoxifen for an additional 5 years is a cost-effective strategy that does not increase all-cause mortality for premenopausal women with estrogen receptor-positive breast cancer, based on an analysis using sophisticated computational modeling techniques. "For premenopausal women with an early estrogen receptor-positive breast cancer who have completed 5 years of tamoxifen as initial treatment, another 5 years of tamoxifen is preferable to ovarian ablation with an aromatase inhibitor as extended endocrine treatment," Janice Kwon, MD , said at the annual meeting of the American College of Obstetricians and Gynecologists. The researchers sought to answer a key clinical question: "What is the optimal endocrine strategy for premenopausal women who have completed 5 years of tamoxifen? Another 5 years of tamoxifen? An aromatase inhibitor preceded by ovarian ablation? Or no further treatment?". Dr. Kwon and her coinvestigators used a ...
BACKGROUND Tamoxifen is frequently used for the treatment of hormone receptor positive breast cancer (BC). Mainly CYP2D6 is responsible for the transformation to therapeutically active metabolites, but CYP2C19, CYP2C9 and CYP2B6 also are involved. We investigated the impact of polymorphisms within the genes encoding these CYP enzymes on the relapse-free time (RFT) in patients with BC. METHODS Ninety-nine patients with hormone receptor positive BC, who had undergone adjuvant tamoxifen therapy, were genotyped for seventeen common variants within the genes encoding CYP2D6, CYP2C9, CYP2C19 and CYP2B6 using TaqMan and PCR-RFLP technology. Kaplan-Meier and Cox regression analyses were performed to elucidate the impact of genetic variants on RFT. Furthermore, CYP2D6 metabolic activity was determined in a subset of 50 patients by assessing dextromethorphan/dextrorphan urinary excretion ratios. CYP2D6 activity was compared to the CYP2D6 allelic combinations to evaluate the predictive value of the CYP2D6 ...
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Phosphorylation of estrogen receptor alpha at serine 305 (ER alpha S305-P) by protein kinase A (PKA) or p21-activated kinase 1 (PAK1) has experimentally been associated with tamoxifen sensitivity. Here, we investigated the clinical application of this knowledge to predict tamoxifen resistance in ER-positive breast cancer patients. Using immunohistochemistry, a score including PAK1 and co-expression of PKA and ER alpha S305-P (PKA/ER alpha S305-P) was developed on a training set consisting of 103 patients treated with tamoxifen for metastatic disease, and validated on 231 patients randomized between adjuvant tamoxifen or no treatment. In the training set, PAK1 levels were associated with tumor progression after tamoxifen (HR 1.57, 95% CI 0.99-2.48), as was co-expression of PKA and ER alpha S305-P (HR 2.00, 95% CI 1.14-3.52). In the validation set, a significant tamoxifen benefit was found among the 73% patients negative for PAK1 and PKA/ER alpha S305-P (HR 0.54, 95% CI 0.34-0.87), while others ...
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BACKGROUND: As trials of 5 years of tamoxifen in early breast cancer mature, the relevance of hormone receptor measurements (and other patient characteristics) to long-term outcome can be assessed increasingly reliably. We report updated meta-analyses of the trials of 5 years of adjuvant tamoxifen. METHODS: We undertook a collaborative meta-analysis of individual patient data from 20 trials (n=21,457) in early breast cancer of about 5 years of tamoxifen versus no adjuvant tamoxifen, with about 80% compliance. Recurrence and death rate ratios (RRs) were from log-rank analyses by allocated treatment. FINDINGS: In oestrogen receptor (ER)-positive disease (n=10,645), allocation to about 5 years of tamoxifen substantially reduced recurrence rates throughout the first 10 years (RR 0.53 [SE 0.03] during years 0-4 and RR 0.68 [0.06] during years 5-9 [both 2p|0.00001]; but RR 0.97 [0.10] during years 10-14, suggesting no further gain or loss after year 10). Even in marginally ER-positive disease (10-19 fmol/mg
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The studys results suggest that the benefits of tamoxifen to prevent cancer can sufficiently compensate for its side effects in post-menopausal women under age 55 years who have an increased risk of developing breast cancer.. Research has shown that tamoxifen can protect against breast cancer for years after treatment ends, but identifying the group of women who can most benefit from the drug as a cancer preventive agent, without experiencing serious side effects, is a challenge. Side effects of the drug can include pulmonary embolism, endometrial cancer, deep vein thrombosis, and cataracts, as well as hot flashes and early menopause.. To investigate those women who would benefit the most from taking tamoxifen as a cancer preventive drug, Peter Alperin, MD, of Archimedes Inc. in San Francisco, and his colleagues used a mathematical model to simulate a post-menopausal population under age 55 years in a virtual clinical trial comparing tamoxifen treatment with no treatment. The investigators ...
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen
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A tamoxifen resistant cell line (clone 9) has been isolated from the tamoxifen sensitive, hormone responsive MCF-7 breast carcinoma cell line after transfection with mixed cDNA libraries, followed by tamoxifen selection in the presence of oestrogens. Transfection was confirmed by Southern analysis with vector probes. Clone 9 in several-fold more resistant to tamoxifen and other anti-oestrogens than wild type cells when cultured either as a monolayer or as colonies in soft agar but retains oestrogen receptors. Clone 9 was less responsive to 17-beta-oestradiol than were wild type MCF-7. In addition to showing in vitro tamoxifen resistance, clone 9 was also tamoxifen resistant in vivo when xenografted into the nude mouse. Culture medium conditioned by clone 9 cells stimulated quiescent cells of the same clone as well as wild type cells, whereas medium conditioned by wild type MCF-7 was inhibitory to both, suggesting that clone 9 may be secreting an autocrine growth factor. Clone 9 provides a novel model
BACKGROUND: Tamoxifen is an important drug for treating breast cancer. Ovarian cancer cells are known to possess receptors for hormones and may thus also respond to tamoxifen. OBJECTIVES: Tamoxifen is used to treat breast cancer in women whose tumours have oestrogen receptors. Since ovarian cancers also commonly have oestrogen receptors, it has been suggested that tamoxifen may be of some benefit. The objective of this review was to assess the effects of tamoxifen in women with relapsed ovarian cancer. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 1, 2009. Cochrane Gynaecological Cancer Group Trials Register, MEDLINE from 2002 to April 2009, EMBASE from 2002 to April 2009. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of review articles and contacted experts in the field, as well as drugs companies. SELECTION CRITERIA: Randomised and non-randomised studies of tamoxifen in women with ovarian cancer who