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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Tamoxifen alone |
|
| Group II | Experimental | Tamoxifen + Aminoglutethimide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen alone | Drug | 2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | ||
| Side-effect profiles |
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Inclusion Criteria:
Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer
Hormone receptor-positive status
More than 6 histologically examined lymph nodes
Laboratory parameters
Concluded healing process following surgery
Less than 4 weeks interval since surgery
Informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raimund Jakesz, MD | Austrian Breast & Colorectal Cancer Study Group | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23511562 | Background | Pfeiler G, Stoger H, Dubsky P, Mlineritsch B, Singer C, Balic M, Fitzal F, Moik M, Kwasny W, Selim U, Renner K, Ploner F, Steger GG, Seifert M, Hofbauer F, Sandbichler P, Samonigg H, Jakesz R, Greil R, Fesl C, Gnant M; ABCSG. Efficacy of tamoxifen +/- aminoglutethimide in normal weight and overweight postmenopausal patients with hormone receptor-positive breast cancer: an analysis of 1509 patients of the ABCSG-06 trial. Br J Cancer. 2013 Apr 16;108(7):1408-14. doi: 10.1038/bjc.2013.114. Epub 2013 Mar 19. | |
| 12637461 |
| Label | URL |
|---|---|
| Click here for more information about this study: publications | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D000616 | Aminoglutethimide |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Tamoxifen + Aminoglutethimide | Drug | 2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years)
|
|
|
| Background |
| Schmid M, Jakesz R, Samonigg H, Kubista E, Gnant M, Menzel C, Seifert M, Haider K, Taucher S, Mlineritsch B, Steindorfer P, Kwasny W, Stierer M, Tausch C, Fridrik M, Wette V, Steger G, Hausmaninger H. Randomized trial of tamoxifen versus tamoxifen plus aminoglutethimide as adjuvant treatment in postmenopausal breast cancer patients with hormone receptor-positive disease: Austrian breast and colorectal cancer study group trial 6. J Clin Oncol. 2003 Mar 15;21(6):984-90. doi: 10.1200/JCO.2003.01.138. |
| 18347178 | Background | Rudas M, Lehnert M, Huynh A, Jakesz R, Singer C, Lax S, Schippinger W, Dietze O, Greil R, Stiglbauer W, Kwasny W, Grill R, Stierer M, Gnant MF, Filipits M; Austrian Breast and Colorectal Cancer Study Group. Cyclin D1 expression in breast cancer patients receiving adjuvant tamoxifen-based therapy. Clin Cancer Res. 2008 Mar 15;14(6):1767-74. doi: 10.1158/1078-0432.CCR-07-4122. |
| 38273214 | Derived | Wimmer K, Hlauschek D, Balic M, Pfeiler G, Greil R, Singer CF, Halper S, Steger G, Suppan C, Gampenrieder SP, Helfgott R, Egle D, Filipits M, Jakesz R, Solkner L, Fesl C, Gnant M, Fitzal F. Is the CTS5 a helpful decision-making tool in the extended adjuvant therapy setting? Breast Cancer Res Treat. 2024 Jun;205(2):227-239. doi: 10.1007/s10549-023-07186-6. Epub 2024 Jan 25. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D005984 | Glutethimide |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |