ARIMIDEX SUMMARY
ARIMIDEX®
Anastrozole
TABLETS
ARIMIDEX® (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor.
ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
The effectiveness of ARIMIDEX in early breast cancer is based on an analysis of recurrence-free survival in patients treated for a median of 31 months (see CLINICAL PHARMACOLOGY
-- Clinical Studies subsection). Further follow-up of study patients will be required to determine long-term outcomes.
ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.
ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
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NEWS HIGHLIGHTSMedia Articles Related to Arimidex (Anastrozole)
Columnists, Cancer Groups Weigh In On Breast Cancer Screening Recommendations
Source: Health News from Medical News Today [2009.11.23]
Several newspapers recently published opinion pieces regarding recent recommendations by the U.S. Preventive Services Task Force that recommend mammograms every two years for most women starting at age 50, rather than at age 40 as previously recommended. The recommendations also say that doctors should not instruct women on breast self-examinations. Summaries of the opinion pieces appear below.
FISH Technology Preferred For Choosing HER-2-Positive Breast Cancer Treatments
Source: Breast Cancer News From Medical News Today [2009.11.22]
The debate on how to select patients who will respond best to costly drug treatments for aggressive breast cancer now favors fluorescence in situ hybridization (FISH) to measure the HER-2 receptor found in human breast tumors, according to a leading pathologist presenting at the Association for Molecular Pathology annual meeting. Michael Press, M.D., Ph.D., pathologist and Harold E.
Secretary Sebelius Statement On New Breast Cancer Recommendations
Source: Breast Cancer News From Medical News Today [2009.11.19]
HHS Secretary Kathleen Sebelius issued the following statement today on new breast cancer screening recommendations from the U.S. Preventive Services Task Force: "There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S.
Some Physicians Say New Breast Cancer Screening Guidelines Unlikely To Alter Their Practices
Source: Breast Cancer News From Medical News Today [2009.11.19]
One day after the release of new breast cancer screening guidelines, many physicians and some medical groups are saying that they do not plan to adopt the new recommendations -- which represent a drastic change -- the New York Times reports (Belluck, New York Times, 11/18). The guidelines, released by the U.S.
Breast Cancer Campaign: New Breast Cancer Research Funding For Belfast
Source: Breast Cancer News From Medical News Today [2009.11.19]
Individualised radiotherapy treatment based on a person's genetic make up could soon become a reality, according to Breast Cancer Campaign. Professor Kevin Prise from Queen's University Belfast has been awarded a three year project grant by the charity to study how genes are involved in the effectiveness of radiotherapy treatment for breast cancer. The grant, worth more than £160,000, is part of £2 million awarded to 20 projects in the UK and Ireland.
Published Studies Related to Arimidex (Anastrozole)
Clomiphene citrate or anastrozole for ovulation induction in women with polycystic ovary syndrome? A prospective controlled trial. [2009.09]
OBJECTIVE: To compare the effects of anastrozole (1 mg) and clomiphene citrate (CC; 100 mg) used for ovulation induction in women with polycystic ovary syndrome... Anastrozole may be helpful in situations in which multiple pregnancy is not desirable or the risk of ovarian hyperstimulation syndrome is high.
Follicular and endocrine response to anastrozole versus clomiphene citrate administered in follicular phase to normoovulatory women: a randomized comparison. [2009.05]
OBJECTIVE: To compare the effect on follicular growth and endocrine parameters of follicular phase administration of anastrozole to healthy, normoovulatory women in doses of 1 or 5 mg, respectively, with the conventional dosing regimen for ovulation induction with clomiphene citrate (CC)... Anastrozole administration results in lower follicular phase E(2) levels.
A randomised study of the effects of letrozole and anastrozole on oestrogen receptor positive breast cancers in postmenopausal women. [2009.04]
INTRODUCTION: Changes in proliferation as measured by Ki67 occur within 14 days of starting treatment with an aromatase inhibitor and these changes have been shown to be predictors of long term outcome. This study aimed to compare changes in proliferation following 14 days of treatment with anastrozole and letrozole...
A comparative study of exemestane versus anastrozole in patients with postmenopausal breast cancer with visceral metastases. [2009.02]
PURPOSE: Patients developing visceral breast cancer metastases generally receive chemotherapy rather than endocrine therapy. Recent aromatase inhibitor studies have reported activity in such patients; therefore, this study formally evaluated anastrozole and exemestane in postmenopausal patients in this setting... CONCLUSION: Efficacy was similar in both treatment groups for all endpoints. Aromatase inhibitors can be considered as a treatment option in postmenopausal patients with hormone receptor-positive visceral breast cancer metastases.
Prevention of anastrozole-induced bone loss with monthly oral ibandronate during adjuvant aromatase inhibitor therapy for breast cancer. [2008.10.01]
CONCLUSIONS: Monthly oral ibandronate improves bone density and normalizes bone turnover in patients treated with anastrozole.
Clinical Trials Related to Arimidex (Anastrozole)
Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer [Completed]
The main purpose of this study is to determine the effects (good and bad) Iressa plus
anastrozole has on patients with relapsed ovarian cancer.
Gynecomastia Extension Study [Completed]
The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in
reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another
anastrozole study).
Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer [Completed]
The purpose of this study is the initial/followed by 5 year adjuvant therapy with
Anastrozole.
Arimidex/Faslodex/Iressa Study: A Trial Using Arimidex, Faslodex and Iressa in Women With Breast Cancer [Active, not recruiting]
The investigators want to know if combining Arimidex and Faslodex with Iressa will be an
effective treatment for breast cancer. They also want to know, using special tests on the
tumor, the changes that occur with the treatment so they can try to improve their treatment
for breast cancer in the future.
Open Label Arimidex in Gynecomastia [Completed]
The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and
pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.
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