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.
You may not be if
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
Clareo Health | A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
