Clinical trial · Interventional
Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women
PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
NCT00237133CI-TRIAL-00026139PREDICTcompletedPhase 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)
Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)
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 |
|---|---|---|---|
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
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 (1)
- measure
- Safety and tolerability of Letrozole
- timeFrame
- frequency and severity of the clinical adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Postmenopausal women 2. Primary locally invasive breast cancer 3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \> 10% positive malignant epithelial cells. 4. Post menopausal status 5. Tumor measurable by clinical examination, mammography and ultrasound Exclusion Criteria: 1. Prior treatment with letrozole or tamoxifen. 2. Patients with bilateral breast tumors 3. Patients who are eligible for breast conserving surgery 4. Evidence of inflammatory breast cancer or distant metastasis. 5. Other concurrent malignant disease 6. Concomitant anti-cancer treatments such as chemotherapy Other protocol-defined exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.