Clinical trial · Interventional
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer
NCT01758146CI-TRIAL-00043773unknownPhase 3ClinicalTrials.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 see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase inhibitors in postmenopausal patients with early breast cancer in terms of: i) Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall survival
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 (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A- Letrozole
- description
- Aromatase inhibitor- letrozole 2.5mg once daily for 5 years
- interventionNames
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- Arm B- Tamoxifen
- description
- Tamoxifen 20 mg once daily for 5 years
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- From date of random assignment to the first event during 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * postmenopausal patients with breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor (PR). * patients with a tumour stage IB, IC, or II irrespective of nodal stage (\< 10 positive nodes) Exclusion Criteria: * premenopausal patients, * ER/PR negative
References
Publications (0)
Data not yet available
No reference posted for this study.