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A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer

RecruitingPhase 2

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

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 76 · Started: Aug 11, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07768436

Locations in the U.S.

New JerseyMemorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering at Bergen (Limited Protocol Activities), Montvale
New YorkMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities), Commack
Memorial Sloan Kettering at Westchester (Limited Protocol Activities), Harrison
Memorial Sloan-Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering at Nassau (Limited Protocol Activities), Uniondale

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.