Clinical trial · Interventional
Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
NCT02583828CI-TRIAL-00073733completedN/AClinicalTrials.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)
This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.
Conditions
Conditions (2)
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 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide 50mg | Drug | Cyclophosphamide | ALIAS |
| Letrozole 2.5 mg | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Cyclophosphamide alone
- description
- Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in this arm will receive cyclophosphamide 50 mg daily.
- interventionNames
- Drug: Cyclophosphamide 50mg
- type
- EXPERIMENTAL
- label
- Cyclophosphamide plus letrozole for resistant patients
- description
- Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
- interventionNames
- Drug: Cyclophosphamide 50mg
- Drug: Letrozole 2.5 mg
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive; * Elderly women (age ≥ 65years) * Failure or relapse from standard chemotherapy or unfit for chemotherapy * Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST); * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * Adequate bone marrow, liver and renal function; * Estimated life expectancy of at least 3 months. Exclusion Criteria: * Serious or uncontrolled concurrent medical illness * Uncontrolled primary and metastatic brain tumor * History of second primary malignancies * Having been enrolled in other clinical trials within a month
References
Publications (0)
Data not yet available
No reference posted for this study.