Clinical trial · Interventional
Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer
Randomised Phase II Study of Metronomic Chemotherapy Plus the Same Aromatase Inhibitor Compared to Metronomic Chemotherapy Alone in Women With Hormone Receptor Positive, Her-2 Non-Overexpressing Advanced Breast Cancer Whose Disease Has Progressed While Receiving an Aromatase Inhibitor, Correlating Response With Circulating Endothelial Progenitor Cells, VEGF and VEGFR
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| exemestane | Drug | Exemestane | ALIAS |
| letrozole | Drug | Letrozole | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive aromatase inhibitor (anastrozole, letrozole, or exemestane) as previously prescribed. Patients also receive oral cyclophosphamide once daily on days 1-28 and oral methotrexate twice on days 15, 16, 22, and 23 of course 1. For all subsequent courses, patients receive oral cyclophosphamide once daily and oral prednisolone once daily on days 1-28 and oral methotrexate twice on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment with cyclophosphamide, methotrexate, and prednisolone repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: anastrozole
- Drug: cyclophosphamide
- Drug: exemestane
- Drug: letrozole
- Drug: methotrexate
- Drug: prednisolone
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive cyclophosphamide, methotrexate, and prednisolone as in arm I.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available