Recruiting

NCT Number: NCT07768436

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

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.

Recruiting

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Key information

Conditions

Adenocarcinoma of the Breast Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMF regimen

Drug

CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil

paclitaxel

Drug

Paclitaxel will be administered as an IV infusion into a peripheral or central vein.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Koshy Alexander, MD, MBA

CONTACT

[email protected]

646-888-3659

Pamela Drullinsky, MD

CONTACT

[email protected]

516-559-1521

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Aug 17, 2026
Registry last updated: Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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