NCT07768436 · Memorial Sloan Kettering Cancer Center
A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
What this study is about
The purpose of this study is to find out if it is practical (feasible) to give dose-dense CMF (cyclophosphamide, methotrexate, and fluorouracil) in two standard chemotherapy regimens in people with breast cancer, age 70 and older.
View original scientific description
The purpose of this study is to find out if it is practical (feasible) to give dose-dense CMF (cyclophosphamide, methotrexate, and fluorouracil) in two standard chemotherapy regimens in people with breast cancer, age 70 and older.
Interventions
DRUG
CMF Regimen
CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil
DRUG
Paclitaxel
Paclitaxel will be administered as an IV infusion into a peripheral or central vein.
Primary outcome measures
Number of participants who have completed all four cycles of CMF
Time frame: 6 months
Evaluate the feasibility of 4 cycles of ddCMF as an alternative to AC in 2 standard regimens in patients \> or = to age 70 with breast cancer. Feasibility is evaluated by the completion of all four cycles of CMF.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSK. The patient must have had diagnostic biopsy or completion of primary surgical management, within 3 months of enrollment. Results of HER-2/neu, estrogen receptor, and progesterone receptor are required for study entry.
- Patients must be ≥ 70 years of age.
- Patients must have ECOG performance status \>2 (Karnofsky score of ≥ 60%).
- Patients may have received hormonal therapy for the purpose of chemoprevention.
- Adjuvant/neoadjuvant chemotherapy decision to treat based on the discretion of investigator
- Cohort 1 only: Patients have any histology except Her 2 Neu positive in the adjuvant or neoadjuvant setting
- Cohort 2 only: Patients have triple negative (ER- (10%) PR-Her 2 Neu -) in the neoadjuvant setting
- Cohort 2 only: Patients have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab in the neoadjuvant setting Required Organ Function Adequate hematologic function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3 Adequate renal function defined as follows: ° Creatinine clearance (CrCL) of \>30 mL/min by the Cockcroft-Gault formula: CrCl (mL/min) = \[(\[140 - age(years)\] x weight (kg))/72 x creatinine (mg/dL)\] (x 0.85 for female patients) Adequate hepatic function defined as follows:
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
- AST and ALT ≤3 x institutional ULN
- Patients or their Legally Authorized Representative must give written, informed consent indicating their understanding and willingness to participate in the study.
Exclusion criteria
- Stage IV breast cancer
- CARG score- high Frail 4 or more as assessed by CAIT
- Her 2 Neu positive 3+/amplified breast cancer
- No prior chemotherapy within 1 year of study enrollment
- Cohort 2 only: patients may not receive pembrolizumab during dd CMF treatment
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations