SECONDARY OBJECTIVES: To determine the anti-tumor effect of the combinations of endocrine therapy with BYL719 in post-menopausal patients with hormone receptor-positive metastatic breast cancer by assessing:. I. Progression free survival (PFS). II. Objective response rate (ORR). III. Clinical benefit rate (complete response [CR]+partial response [PR]+stable disease [SD] ,= 6 months).. EXPLORATORY OBJECTIVES:. I. Pharmacokinetics of BYL719 in combination with letrozole: Plasma concentration-time profiles and derived basic pharmacokinetic (PK) parameters of BYL719 and letrozole, including but not limited to area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-tlast), AUC curve to infinite time (AUC0-inf), maximum observed concentration (Cmax), time to peak concentration (Tmax), clearance over bioavailability (CL/F), apparent volume of distribution (Vz/F) and the terminal half-life (t1/2) and other PK parameters if deemed appropriate.. II. ...
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TY - JOUR. T1 - Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. AU - Hortobagyi, Gabriel N.. AU - Stemmer, S. M.. AU - Burris, H. A.. AU - Yap, Y. S.. AU - Sonke, G. S.. AU - Paluch-Shimon, S.. AU - Campone, M.. AU - Petrakova, K.. AU - Blackwell, K. L.. AU - Winer, E. P.. AU - Janni, W.. AU - Verma, S.. AU - Conte, P.. AU - Arteaga, C. L.. AU - Cameron, D. A.. AU - Mondal, S.. AU - Su, F.. AU - Miller, M.. AU - Elmeliegy, M.. AU - Germa, C.. AU - OShaughnessy, J.. PY - 2018/7/1. Y1 - 2018/7/1. N2 - Background: The phase III MONALEESA-2 study demonstrated significantly prolonged progression-free survival (PFS) and a manageable toxicity profile for first-line ribociclib plus letrozole versus placebo plus letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Here, we ...
Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR) -positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5%]; anastrozole, 368 [17.7%]). The 5-year estimated DFS rate was 84.9% for ...
The drug palbociclib, an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, significantly improved progression-free survival when administered as a first-line treatment in patients with hormone receptor-positive, metastatic ...
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This was the first clinical trial initiated to explore the hypothesis that activation of the HER pathway during tamoxifen treatment in ER-positive tumors contributes to acquired resistance. It was further hypothesized that simultaneous blockade of HER receptors and ER may delay this resistance even in tumors with low initial levels of EGFR/HER2 because expression of these proteins can increase when ER is blocked. The EGFR inhibitor gefitinib was chosen because it inhibits signaling from EGFR homo- and heterodimers and because it was effective in preclinical studies in which upregulation of EGFR was a dominant characteristic of tamoxifen-resistant tumors (16-18, 20, 21).. This randomized phase II trial was not designed to show a statistically significant advantage for the addition of gefitinib to tamoxifen, but rather to determine whether the addition of gefitinib resulted in a numerical advantage compared with placebo of sufficient interest to warrant further study. This proof-of-concept trial ...
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The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 when used together with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed initial safety,tolerability and good bioavailability of both drugs and determined the doses for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in combination with AZD0530. The Phase II cohort will permit extended assays of tolerability, initial estimates of efficacy, and the investigation of molecular predictors of drug ...
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Many important food crops produce cyanogenic glucosides as natural defense compounds to protect against herbivory or pathogen attack. It has also been suggested that these nitrogen-based secondary metabolites act as storage reserves of nitrogen. In sorghum, three key genes, CYP79A1, CYP71E1 and UGT85B1, encode two Cytochrome P450s and a glycosyltransferase, respectively, the enzymes essential for synthesis of the cyanogenic glucoside dhurrin. Here, we report the use of targeted induced local lesions in genomes (TILLING) to identify a line with a mutation resulting in a premature stop codon in the N-terminal region of UGT85B1. Plants homozygous for this mutation do not produce dhurrin and are designated tcd2 (totally cyanide deficient 2) mutants. They have reduced vigor, being dwarfed, with poor root development and low fertility. Analysis using liquid chromatography-mass spectrometry (LC-MS) shows that tcd2 mutants accumulate numerous dhurrin pathway-derived metabolites, some of which are ...
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This study compared the efficacy, tolerability and quality-of-life (QoL) effects of adjuvant anastrozole then letrozole versus letrozole then anastrozole in
A class of oral drugs for treating breast cancer known as cyclin-dependent kinase (CDK) 4/6 inhibitors are generally well-tolerated, with a manageable toxicity profile for most patients. This is the conclusion of a comprehensive review of toxicities and drug interactions related to this class of drugs, published by Spring et al in The Oncologist.. The excitement surrounding CDK4/6 inhibitors is due to their potential for treating hormone receptor-positive metastatic breast cancer, the most common form of the disease. The first CDK4/6 inhibitors were recently approved by the U.S. Food and Drug Administration (FDA), with palbociclib (Ibrance) approved in February 2015 and ribociclib (Kisqali) approved in March 2017. A third, abemaciclib, is currently undergoing phase III trials. All three CDK4/6 inhibitors have received Breakthrough Therapy designation from the FDA.. "CDK inhibitors have changed the landscape of management of hormone receptor-positive breast cancer," said Aditya Bardia, MBBS, MPH, ...
Although there was less toxicity, neoadjuvant letrozole plus palbociclib had similar response and BCS rates when compared with chemotherapy.
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Letz from Chemech, Letrozole - Anolet to Oncolet | Letrozole is an oral non-steroidal aromatase inhibitor for the treatment of hormonally-responsive breast cancer after surgery. Use of Letz from Chemech, Pregnancy, lactation in childrens and special precautions for Letz from Chemech, prices of Letz from Chemech . Estrogens are produced by the conversion of androgens through the activity of the aromatase enzyme. Estrogens then bind to an estrogen receptor, which causes cells to divide. Letrozole prevents the aromatase from producing estrogens by competitive, reversible binding to the heme of its cytochrome P450 unit. The action is specific, and letrozole does not reduce production of mineralo- or corticosteroids.In contrast, tamoxifen interferes with the estrogen receptor. Tamoxifen is also used to treat hormonally- responsive breast cancer. However, letrozole is effective only in post-menopausal women, in whom estrogen is produced predominantly by the adrenal glands. In pre-menopausal women, estrogen is
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... is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.. ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.. For more information, see your doctor. Please see full Prescribing Information.. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.. ...
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.. There are certain circumstances and medical conditions where this medication is not recommended, or should be taken with caution. Be sure to inform your physician of all your medical conditions before you begin therapy.. Bone mineral density: Long-term use of anastrozole may decrease the density of bones, thereby increasing the risk of osteoporosis. Your doctor will order bone mineral density tests periodically while you are taking anastrozole.. Drowsiness/dizziness: Anastrozole may cause dizziness or drowsiness. If you experience either or both of these side effects, you should not drive, use machinery, or perform any other activities that require alertness.. Heart disease: This medication ...
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After a median follow-up of five years, 40 women in the Arimidex group (2%) and 85 women in the placebo group (4%) had developed breast cancer. The predicted cumulative incidence of all breast cancers after seven years was 5.6 percent in the placebo group and 2.8 percent in the Arimidex group. The number needed to treat was 36 to prevent one breast cancer in seven years of follow-up. Side effects associated with estrogen deprivation, were only slightly more frequent in the Arimidex group than in the placebo group. ...
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Arimidex (generic name Anastrozole), being an effective medication, can significantly decrease the level of estrogen in the organism of postmenstrual women. Consequently, the medication reduces not only the rate of estrogen in the organism, but its supply to the breast tumors that require it for development and spreading.
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