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A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | fulvestrant and anastrozole |
|
| 2 | Experimental | fulvestrant and placebo |
|
| 3 | Active Comparator | exemestane alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fulvestrant | Drug | Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | every 3 months during treatment and, at time of discontinuation from treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective complete response (CR) and partial response (PR) rate | every 3 months during treatment and, at time of discontinuation from treatment | |
| Duration of response | every 3 months during treatment and, at time of discontinuation from treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Huck Im | Professor(Samsung Medical Center) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ilsan | South Korea | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23902874 | Derived | Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29. |
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| anastrozole | Drug | Tablet, oral, once daily until disease progression. |
|
|
| exemestane | Drug | Tablet, oral, once daily until disease progression. |
|
|
| Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate | every 3 months during treatment and, at time of discontinuation from treatment |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D000077384 | Anastrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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