Study on Cyclophosphamide, Methotrexate, and Fluorouracil (CMF) for Older Adults with Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07768436
This clinical trial is exploring whether a specific chemotherapy treatment, called dose-dense CMF, is practical for people aged 70 and older with breast cancer. The study aims to determine if this treatment can be effectively given in two standard chemotherapy regimens.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to see if a chemotherapy treatment using three drugs—cyclophosphamide, methotrexate, and fluorouracil (CMF)—can be given safely and effectively to people aged 70 and older with breast cancer. Researchers want to find out if this treatment approach is feasible for older adults.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of breast cancer.
- Must be 70 years or older.
- Must be in relatively good health, with a performance status score greater than 2.
- May have received hormonal therapy to prevent cancer.
- Treatment decisions will be made by the study doctor.
- For Cohort 1: Any type of breast cancer except HER2 positive.
- For Cohort 2: Triple negative breast cancer and have received at least one dose of carboplatin/paclitaxel, with or without pembrolizumab.
Required Organ Function:
- Blood health: Neutrophil count of at least 1,500 cells/mm3 and platelets of at least 100,000 cells/mm3.
- Kidney health: Creatinine clearance greater than 30 mL/min.
- Liver health: Total bilirubin no more than 1.5 times the normal limit (up to 3 times for those with Gilbert's disease), and AST/ALT no more than 3 times the normal limit.
- Must provide written consent to participate.
Exclusion Criteria
- Stage IV breast cancer.
- High frailty score of 4 or more.
- HER2 positive breast cancer.
- No chemotherapy within one year before joining the study.
- For Cohort 2: Cannot receive pembrolizumab during CMF treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering at Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering at Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan-Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering at Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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