A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CMF Regimen
DrugCMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil
Paclitaxel
DrugPaclitaxel will be administered as an IV infusion into a peripheral or central vein.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who have completed all four cycles of CMF
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.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov