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The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.
This study aimed at evaluating following:
Validity Assessment:
Safety Assessment: To evaluate all adverse events including serious adverse events after Letrozole treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ER expression : Low | Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 3 or 4 point of total Allred score. | ||
| ER expression : Intermediate | Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 5 or 6 point of total Allred score. | ||
| ER expression : High | Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 7 or 8 point of total Allred score. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | the first 5 years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect | the first 5 years after enrollment | |
| Overall Survival | the first 5 years after enrollment | |
| Time to Distant Recurrence (TTDR) |
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Inclusion Criteria:
Patients with estrogen receptor(+) and/or progesterone receptor(+)
Postmenopausal state was defined the following conditions, at least one of a, b
Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
WHO(ECOG) performance status 0-2
Adequate haematological function, renal function, hepatic function.
No evidence of metastasis.
Exclusion Criteria:
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Patients recruited into the study are postmenopausal women with estrogen receptor positive breast cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ku Sang Kim, MD | Contact | 82-31-219-5200 | ideakims@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Joon Jeong, MD | Department of Surgery, Gangnam Severance Hospital, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joon Jeong | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33818022 | Derived | Ahn SG, Nam SJ, Ahn SH, Jung Y, Park HK, Lee SJ, Kang SS, Han W, Park KH, Park YL, Lee J, Youn HJ, Kim JH, Yoo Y, Song JY, Ko BK, Gwak G, Chung MS, Kim SY, Cho SH, Kim D, Chang MC, Moon BI, Kim LS, Kim SJ, Park MH, Kim TH, Cho J, Lim CW, Bae YT, Gong G, Bae YK, Lee A, Jeong J. Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006). J Breast Cancer. 2021 Apr;24(2):164-174. doi: 10.4048/jbc.2021.24.e17. Epub 2021 Mar 25. |
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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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Breast Cancer Tissue
| the first 5 years after enrollment |
| D017437 |
| Skin and Connective Tissue Diseases |