NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Conditions: Adenocarcinoma of the Breast, Breast Cancer, Triple Negative Breast Cancer

Interventions: CMF Regimen, Paclitaxel

Countries: United States

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 overview

Sex: ALL

Age: 70 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (7)

Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
Uniondale, New York, United States