Clinical trial · Interventional
Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer
Antiestrogen vs Aromatase Inhibitor After Chemotherapy for Adjuvant Setting: Efficacy of Endocrine Therapy After Chemotherapy in Postoperative Adjuvant Therapy for Breast Cancer
NCT00437359CI-TRIAL-00006634terminatedPhase 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 benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in 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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Toremifene citrate | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Fareston
- description
- Toremifene citrate: 40-mg tablets by mouth once daily.
- interventionNames
- Drug: Toremifene citrate
- type
- OTHER
- label
- Arimidex
- description
- Anastrozole: 1-mg tablets by mouth once daily.
- interventionNames
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Recurrence-free rate
- timeFrame
- The observation period is designated as 10 years from the commencement of treatment.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Written consent obtained for study participation. * Breast cancer diagnosed histologically with a breast removed or preserved. * Positive ER or PR testing by immunohistochemistry (IHC), enzyme immunoassay (EIA) and who meet the criteria of each institution. * HER2 evaluation. * Patient Status (PS): 0 or 1. * Fully functional heart, liver, kidneys, and bone marrow. * More than one year since last menstruation or tested postmenopausal from estradiol (E2) and follicle-stimulating hormone (FSH) levels based on evaluation standard of each institution. * Expected to live for at least three months (or longer) after study commencement. Exclusion Criteria: * Pregnant or breast feeding. * Bilateral or inflammatory breast cancer. * Multiple cancers. * Life-threatening metastases. * History of serious hypersensitivity. * Judged ineligible for the study by the study doctor.
References
Publications (0)
Data not yet available
No reference posted for this study.