Dysautonomia International

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

Purpose

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.

Conditions

Adenocarcinoma of the Breast
Breast Cancer
Triple Negative Breast Cancer

Eligibility

Eligible Ages: Over 70 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1	ddCMF x 4 Cycles followed by either 4 doses of dd paclitaxel given every 2 weeks or 12 doses of paclitaxel given weekly, per investigator discretion, in the adjuvant or neoadjuvant setting	Drug: CMF Regimen CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil Drug: Paclitaxel Paclitaxel will be administered as an IV infusion into a peripheral or central vein.
Experimental Cohort 2	ddCMF x 4 Cycles in the neoadjuvant setting, in participants who have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab	Drug: CMF Regimen CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil

Recruiting Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920