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A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for the Treatment Breast Cancer
Trial Status: active
This phase II trial studies how well giving cyclophosphamide, methotrexate, and fluorouracil every 2 weeks (dose dense) with and without paclitaxel works in treating breast cancer patients age 70 and older. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell’s deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body’s immune response. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make DNA and may kill tumor cells. Fluorouracil is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving cyclophosphamide, methotrexate, and fluorouracil on a dose dense schedule with and/or without paclitaxel may be an effective way to treat breast cancer patients age 70 and older.
Inclusion Criteria
Patients must have histologically confirmed adenocarcinoma of the breast confirmed at Memorial Sloan Kettering (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 Eastern Cooperative Oncology Group (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
Creatinine clearance (CrCL) of > 30 mL/min by the Cockcroft-Gault formula
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)
Aspartate aminotransferase (AST) =< 3 x institutional ULN
Alanine aminotransferase (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 Cancer and Aging Interprofessional Team (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07768436.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Pamela R Drullinsky
Phone: 212-987-1777
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Pamela R Drullinsky
Phone: 212-987-1777
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Pamela R Drullinsky
Phone: 212-987-1777
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Pamela R Drullinsky
Phone: 212-987-1777
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Pamela R Drullinsky
Phone: 212-987-1777
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Pamela R Drullinsky
Phone: 212-987-1777
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Pamela R Drullinsky
Phone: 212-987-1777
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of 4 cycles of dose dense cyclophosphamide, methotrexate, fluorouracil (ddCMF) as an alternative to doxorubicin (Adriamycin), cyclophosphamide (Cytoxan) (AC) in 2 standard regimens in patients > or = to age 70 with breast cancer.
SECONDARY OBJECTIVES:
I. Report outcome pathologic complete response (pCR) and pathologic partial response (pPR) in patients who are treated in the neoadjuvant setting.
II. Cancer and Aging Research Group (CARG) utility in aiding chemotherapy tolerance for patients greater or equal to 70 for the standard portions of the regimens.
III. Observational description of chemotherapy dose adjustments and complications.
OUTLINE: Patients with any histology except human epidermal growth factor receptor 2 (Her 2 Neu) positive in the adjuvant or neoadjuvant setting are assigned to Cohort 1. Patients with triple negative (estrogen receptor negative [ER-] [10%] progesterone receptor negative [PR-] Her 2 Neu negative [-]) in the neoadjuvant setting are assigned to Cohort 2.
COHORT 1: Patients receive cyclophosphamide intravenously (IV), methotrexate IV, and fluorouracil IV on day 1 of each cycle. Cycles repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Following the completion of 4 cycles of ddCMF and at the discretion of the investigator, patients then receive either paclitaxel IV once every two weeks (Q2W) for up to 4 doses or paclitaxel IV once a week (QW) for up to 12 doses in the absence of disease progression or unacceptable toxicity. Patients who receive treatment in the neoadjuvant setting transition to standard of care therapy post-paclitaxel per primary care team.
COHORT 2: Patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1 of each cycle. Cycles repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Following the completion of 4 cycles of ddCMF, patients then transition to standard of care therapy per primary care team.
After completion of study treatment, patients are followed up at 30 days, 6 months, and 12 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
