Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclophosphamide alone | Active Comparator | 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 plus letrozole for resistant patients | Experimental | 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 plus letrozole for treat-naive patients | Experimental | 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. |
|
| letrozole alone | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide 50mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) of the subjects | Time from the randomization date to the start of disease progression or subject death from any cause (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1for elderly metastatic breast cancer subjects). | up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of each treatment regimen for the subjects | Assessment based on Adverse Events (AEs) , Serious Adverse Events (SAEs), laboratory abnormalities in subjects . | up to approximately 2 years |
| Evaluate the quality of life for the subjects in the each treatment regimen |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital | Beijing | 100038 | China |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Letrozole 2.5 mg | Drug |
|
Subjects complete questionnaire in every 8 weeks. |
| up to approximately 2 years |
| Compare disease control rate for the subjects | Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks. | up to approximately 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |