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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR ARIMIDEX


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All Clinical Trials for ARIMIDEX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005908 ↗ Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer Completed National Cancer Institute (NCI) Phase 2 2000-06-01 This study will assess the usefulness of a technique called complementary deoxyribonucleic acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study will look for "markers" that can help select the most effective type of chemotherapy. It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel. Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study. Those enrolled will be treated with surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), and the capecitabine and docetaxel combination. Patients will have a physical examination, mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment. They will then have four 21-day treatment cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be given from days 16 through 21. This regimen will be repeated four times, after which the tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance imaging. Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four 21-day cycles. Some patients who had a mastectomy (depending on their tumor characteristics and whether tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also have radiation therapy. Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years. In addition to the above procedures, all patients will have tumor biopsies (removal of a small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2, and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood tests at various times during the study. Patients will be followed at National Institutes of Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and computed tomography (CT) scans. Although it is not known whether this treatment will help an individual patient's cancer, possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition, the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted.
NCT00022672 ↗ A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer Completed Genentech, Inc. Phase 3 2001-01-01 This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
NCT00022672 ↗ A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer Completed Hoffmann-La Roche Phase 3 2001-01-01 This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
NCT00049062 ↗ Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer Completed The University of Texas Health Science Center at San Antonio Phase 2 2002-09-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.
NCT00055302 ↗ Arimidex in McCune Albright Syndrome Completed AstraZeneca Phase 2 2002-08-01 The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.
NCT00057941 ↗ Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 2003-09-01 This randomized phase II trial is studying how well giving gefitinib together with anastrozole works compared to giving gefitinib together with fulvestrant in treating postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ARIMIDEX

Condition Name

Condition Name for ARIMIDEX
Intervention Trials
Breast Cancer 67
Stage IV Breast Cancer 8
HER2/Neu Negative 7
Recurrent Breast Cancer 7
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Condition MeSH

Condition MeSH for ARIMIDEX
Intervention Trials
Breast Neoplasms 112
Carcinoma 12
Endometrial Neoplasms 4
Breast Neoplasms, Male 4
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Clinical Trial Locations for ARIMIDEX

Trials by Country

Trials by Country for ARIMIDEX
Location Trials
United States 420
Japan 43
Canada 36
Spain 30
United Kingdom 24
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Trials by US State

Trials by US State for ARIMIDEX
Location Trials
Massachusetts 21
California 20
Texas 18
Florida 18
Missouri 16
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Clinical Trial Progress for ARIMIDEX

Clinical Trial Phase

Clinical Trial Phase for ARIMIDEX
Clinical Trial Phase Trials
Phase 4 6
Phase 3 38
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for ARIMIDEX
Clinical Trial Phase Trials
Completed 78
Recruiting 20
Terminated 20
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Clinical Trial Sponsors for ARIMIDEX

Sponsor Name

Sponsor Name for ARIMIDEX
Sponsor Trials
AstraZeneca 54
National Cancer Institute (NCI) 21
Pfizer 9
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Sponsor Type

Sponsor Type for ARIMIDEX
Sponsor Trials
Other 154
Industry 112
NIH 29
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