Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients | NCT02583828 | Trialant
CompletedInterventionalNot ApplicableUpdated Feb 7, 2024
Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
ClinicalTrials.gov ID
NCT02583828
Lead Sponsor
Capital Medical UniversityOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
200Actual
Last Update Posted
Feb 7, 2024Actual
Start Date
Jun 2015
Primary Completion Date
Dec 2020Actual
Completion Date
Dec 2021Actual
Brief Summary
This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.
Breast Neoplasms
Neoplasm Metastasis
Cyclophosphamide 50mg
Letrozole 2.5 mg
Ages Eligible for Study
Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital