Status:
UNKNOWN
Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 th...
Detailed Description
OBJECTIVES: Primary * Compare the clinical benefit rate (complete response, partial response or stable disease for \> 24 weeks) in postmenopausal women with metastatic breast cancer treated with met...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Metastatic disease
- Measurable disease, as defined by RECIST criteria
- Evidence of disease progression while receiving a third-generation aromatase inhibitor
- No extensive visceral disease (\> 50% liver or lung parenchymal involvement)
- No pleural effusion or ascites
- No HER2/neu overexpression
- Hormone receptor status:
- Estrogen receptor- or progesterone receptor-positive tumor
- PATIENT CHARACTERISTICS:
- Postmenopausal, as defined by any of the following:
- Over 60 years of age
- 50-59 years of age with plasma follicle-stimulating hormone, luteinizing hormone, and estradiol in the postmenopausal range and amenorrhea for \> 1 year
- Any age with documented bilateral oophorectomy
- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- Life expectancy \> 6 months
- Leukocytes ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Total bilirubin normal
- AST/ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant
- Fertile patients must use effective contraception
- No other prior malignancies except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, methotrexate, prednisolone, anastrozole, letrozole, or exemestane
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- PRIOR CONCURRENT THERAPY:
- No more than 2 lines of prior chemotherapy or endocrine therapy for advanced disease
- No other concurrent chemotherapy, immunotherapy, anticancer hormonal therapy, or anticancer surgery
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent combination anti-retroviral therapy for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00687648
Start Date
May 1 2008
Last Update
June 17 2009
Active Locations (1)
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1
National Cancer Centre - Singapore
Singapore, Singapore, 169610