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A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
STUDY OF DOSE DENSE CMF (Cyclophosphamide, Methotrexate, Fluorouracil) as an Alternative to AC (Doxorubicin, Cyclophosphamide) in 2 Regimens in EARLY STAGE BREAST CANCER for Patients Greater or Equal to 70
Who can join
Ages 70 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- CMF Regimen (drug)
- Paclitaxel (drug)
Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 76 · Started: Aug 11, 2026
Contact the study team
- Pamela Drullinsky, MD · Phone: 516-559-1521
- Koshy Alexander, MD, MBA · Phone: 646-888-3659
Official record on ClinicalTrials.gov — NCT07768436
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.