Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Treatments: Anastrozole; Aromatase Inhibitors; Cyclophosphamide; Exemestane; Letrozole; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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