Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer
NCT00687648 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2009-06-17
Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole, letrozole, or exemestane may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving combination chemotherapy together with aromatase inhibitor therapy is more effective than combination chemotherapy alone in treating breast cancer.
PURPOSE: This randomized phase II trial is studying giving cyclophosphamide, methotrexate, and prednisolone together with aromatase inhibitor therapy to see how well it works compared with cyclophosphamide, methotrexate, and prednisolone in treating postmenopausal women with metastatic breast cancer.
Conditions
Interventions
- DRUG
-
anastrozole
Given as previously prescribed
- DRUG
-
Given by mouth
- DRUG
-
exemestane
Given as previously prescribed
- DRUG
-
Given as previously prescribed
- DRUG
-
methotrexate
Given by mouth
- DRUG
-
prednisolone
Given by mouth
Sponsors & Collaborators
-
National Cancer Centre, Singapore
lead OTHER
Principal Investigators
-
Wong Nan Soon, MBBS, MRCP, FAMS · National Cancer Centre, Singapore
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2010-04-30
Countries
- Singapore
Study Locations
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