Clinical trial · Observational
Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women
Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
NCT01069211CI-TRIAL-00004800LETTERunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- ER expression : Low
- description
- Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 3 or 4 point of total Allred score.
- label
- ER expression : Intermediate
- description
- Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 5 or 6 point of total Allred score.
- label
- ER expression : High
- description
- Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 7 or 8 point of total Allred score.
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- the first 5 years after enrollment
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patients with estrogen receptor(+) and/or progesterone receptor(+) 2. Postmenopausal state was defined the following conditions, at least one of a, b 1. Serum FSH ≥ 30 mIU/mL and Amenorrhea ≥ 1 year for below 55 years, over than 55 years 2. Bilateral oophorectomy 3. Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks. 4. WHO(ECOG) performance status 0-2 5. Adequate haematological function, renal function, hepatic function. 6. No evidence of metastasis. Exclusion Criteria: 1. Metachronous bilateral breast cancer. 2. Metastatic breast cancer (stage IV) 3. Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream. 4. Patients with Child-Pugh grade C, serum creatinine\>2xUNL 5. Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
References
Publications (1)
- DERIVEDAhn 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. PMID 33818022