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Arimidex™ (anastrozole) Clinical Trial report summaries

Arimidex™ (anastrozole) is an aromatase inhibitor approved in many countries for use in postmenopausal women with hormone-sensitive early or advanced breast cancer.

Please consult the prescribing information for the country concerned for guidance on the approved use of Arimidex™ (anastrozole).

Study Number Completed Clinical Trial Report Summaries

1033GR/0001 ARNO 

A prospective, multi-centre, randomised, open parallel group study to compare the effectiveness and compatibility of ARIMIDEX (ZD 1033) with NOLVADEX after a prior 2 years’ treatment with tamoxifen in adjuvant therapy of breast carcinoma in postmenopausal women

1033IL/0029 ATAC

A Randomised, Double-blind Trial Comparing ARIMIDEX™ Alone with NOLVADEX™ Alone with ARIMIDEX and NOLVADEX in Combination, as Adjuvant Treatment in Postmenopausal Women with Breast Cancer

1033IA/0029

A Randomised, Double-blind Trial to Assess the Pharmacokinetics of ARIMIDEX™ Alone, NOLVADEX™ Alone, or ARIMIDEX and NOLVADEX in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

1033IC/0029

A Randomised, Double-blind Trial to Assess the Incidence of Endometrial Changes with ARIMIDEX™ Alone, NOLVADEX™ Alone, or ARIMIDEX and NOLVADEX in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

D5392C01985

(1033ID/0029)

A Randomised, Double-blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of ARIMIDEX™ Alone, NOLVADEX™ Alone, or ARIMIDEX and NOLVADEX in Combination, (in Comparison to a Control Group) When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women.
1033IE/0029A Randomised, Double-blind Trial to assess Quality of Life with ARIMIDEX™ Alone, NOLVADEX™ Alone, or ARIMIDEX and NOLVADEX in Combination, when used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women

1033IL/0027

A Randomised, Double-blind, Double-dummy Trial to Compare the Efficacy and Safety of ARIMIDEX™ (ZD1033 1 mg Daily) with Tamoxifen (20 mg Daily) as First-line Therapy for Advanced Breast Cancer in Postmenopausal Women

1033IL/0030 TARGET

A Randomized, Double-blind Trial to Compare the Efficacy and Safety of Anastrozole (ARIMIDEX™ 1 mg Daily) With Tamoxifen Citrate (20 mg Daily) as First-line Therapy for Advanced Breast Cancer in Postmenopausal Women

1033IL/0039 PROACT

A randomised, double-blind, study comparing ARIMIDEX™ with NOLVADEX™ as neo-adjuvant and adjuvant treatment in postmenopausal women with large operable (T2 [≥3 cm], T3, N0-2, M0) or potentially-operable, locally advanced (T4b, N0-2, M0), ER+ and/or
PR+ breast cancer

 

1033IL/0030 and 1033IL/0027

 

Randomised, Double-blind Trials to Compare the Efficacy and Safety of ARIMIDEX™ (Anastrozole 1 mg Daily) with Tamoxifen (20 mg Daily) as First line Therapy for Advanced Breast Cancer in Postmenopausal Women: Safety and Survival Update 2001

1033AU/0001
ABCSG 6A

A randomised, open, comparative multicentre trial (Protocol 6a) in postmenopausal patients with breast cancer who have been treated with Tamoxifen postoperatively for 5 years as adjuvant hormone-therapy comparing the aromatase inhibitor Anastrozole for 3 years with an untreated controlgroup.

1033US/0006

A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of Anastrozole (ZD1033, ARIMIDEX™) versus Placebo for the Treatment of Gynecomastia in Pubertal Boys.

D5392NL002 ARREST 

Arimidex; Reason for and effect of change from tamoxifen

D5392C00050 SABRE

A multicentre phase III/IV study, of the effects of risedronate sodium (ACTONEL™, 35 mg/week, oral) on bone, in postmenopausal women, with hormone-receptor-positive early breast cancer, treated with anastrozole
(ARIMIDEX™, 1 mg/day oral) with either high-risk of fragility fracture (open-label, non-comparative stratum), or moderate-risk of fragility fracture (randomised, double-blind stratum), and of the effects of anastrozole
(ARIMIDEX™, 1 mg/day oral) on bone, in postmenopausal women, with hormone-receptor-positive early breast cancer, and low-risk of fragility fracture (open-label, non-comparative stratum)

D5394C00046

An Open-label Study Evaluating the Safety and Efficacy of Anastrozole (ARIMIDEX™) in the Treatment of Precocious Puberty in Girls with McCune-Albright Syndrome.

D5394C00001

An Open-label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (ARIMIDEX™) Used to Treat Pubertal Boys with Gynecomastia of Recent Onset

NIS-ARO-HCH-2006-1

ARIMIDEX Study ( Non-interventional study to evaluate Arimidex in adjuvant therapy in partial or complete response or stabilized disease after first line chemotherapy in postmenopausal women with advanced breast cancer).



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