A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
Recruiting · NCT07768436 · Interventional (participants receive a specific treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
CMF RegimenPaclitaxel
What this trial 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.
Who can take part
Age range
70 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
7 locations listed across 2 US states.
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) - Middletown, New Jersey, United States
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) - Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) - Commack, New York, United States
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) - Harrison, New York, United States
- Memorial Sloan-Kettering Cancer Center (All Protocol Activities) - New York, New York, United States
- Memorial Sloan Kettering at Nassau (Limited Protocol Activities) - Uniondale, New York, United States