Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
NCT ID: NCT02583828
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2015-06-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cyclophosphamide alone
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.
Cyclophosphamide 50mg
Cyclophosphamide plus letrozole for resistant patients
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.
Cyclophosphamide 50mg
Letrozole 2.5 mg
Cyclophosphamide plus letrozole for treat-naive patients
Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
Cyclophosphamide 50mg
Letrozole 2.5 mg
letrozole alone
Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive letrozole 2.5 mg daily.
Letrozole 2.5 mg
Interventions
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Cyclophosphamide 50mg
Letrozole 2.5 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* Uncontrolled primary and metastatic brain tumor
* History of second primary malignancies
* Having been enrolled in other clinical trials within a month
65 Years
FEMALE
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Jun Ren MD, PhD
MD, PhD
Locations
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Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Beijing, , China
Countries
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Other Identifiers
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LET+CTX
Identifier Type: -
Identifier Source: org_study_id
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