Clinical trial · Interventional
Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene
NCT01072318CI-TRIAL-00003179LEXTOPunknownPhase 4ClinicalTrials.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 Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Letrozole, DFS
- description
- Efficacy evaluation of extended letrozole after 5 year fareston use
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
- Disease free survival rate
- timeFrame
- 3 years
Secondary outcomes (4)
- measure
- Disease free survival rate
- timeFrame
- 12 months, 24 months
- measure
- Distant disease free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer. 2. Removed the breast cancer histologically or cytologically 3. No evidence of breast cancer in controlateral breast 4. No evidence of metastasis 5. Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months 6. Postmenopausal state was defined the following conditions, at least one of a, b 1. Serum FSH ≥ 30 mIU/mL 2. Amenorrhea ≥ 1 year 7. Estrogen receptor(+) or Progesterone receptor(+) 8. No Evidence of Recurrence Exclusion Criteria: 1. Patient with hormone receptor negative 2. Patients with malignancies 3. Patients with other aromatase inhibitor and chemotherapy 4. Patients with Other hormone therapy and Hormonal replacement therapy 5. Patients with Hormone replacement therapy during taking Toremifene 6. Estimated life expectancy of \<12 months 7. WBC\<3,000/mm3 or Platelet count\<100,000/mm3 8. AST and/or ALT ≥2xUNL 9. Alkaline phosphatase ≥2xUNL
References
Publications (0)
Data not yet available
No reference posted for this study.