Clinical trial · Interventional
Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
NCT00237211CI-TRIAL-00035762completedPhase 2ClinicalTrials.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)
To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.
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 |
|---|---|---|---|
| Postmenopausal Women With Advanced Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Letrozole
- interventionNames
- Drug: Letrozole
Primary outcomes (2)
- measure
- Safety during treatment
- timeFrame
- Until disease progression or appearance of unacceptable toxicity whichever comes first
- measure
- Response Rate during treatment
- timeFrame
- Until disease progression or appearance of unacceptable toxicity whichever comes first
Secondary outcomes (4)
- measure
- Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically documented breast cancer. * Patients with hormone receptor (ER and/or PgR) status of positive or unknown * Patients who have been amenorrheic for the preceding 12 months or more. * Patients who are 20 years or older and younger than 75 years. * Patients with a history of postoperative adjuvant therapy or a history of endocrine therapy with tamoxifen for the treatment of progression or recurrence of the lesion. The endocrine therapy, however, should not exceed one regimen. * Patients with progressing lesions. * Patients with sufficient organ function to evaluate the safety * Patients whose performance status (PS) is classified in 0～2. * Patients who have no residual effects from previous treatments Exclusion Criteria: * Patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ). * Patients with hypercalcemia and uncontrollable cardiac disease (including a history of serious cardiac disease) * Patients who have previously received aromatase inhibitor. * Patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis. Other protocol-defined inclusion / exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.