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RecruitingPhase 2

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

STUDY OF DOSE DENSE CMF (Cyclophosphamide, Methotrexate, Fluorouracil) as an Alternative to AC (Doxorubicin, Cyclophosphamide) in 2 Regimens in EARLY STAGE BREAST CANCER for Patients Greater or Equal to 70

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
70 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether CMF chemotherapy can be given with less time between treatments using two standard treatment plans. CMF combines cyclophosphamide, methotrexate, and fluorouracil. The study is for people age 70 or older with breast cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 70 or older.
  • MSK must confirm your breast cancer using a tissue sample. Your biopsy or main surgery must have been within 3 months before joining. HER2 and hormone receptor test results are needed.
  • You must meet the listed activity scores: ECOG above 2 and Karnofsky at least 60%. These scores measure how well you can do daily tasks.
  • The study doctor must decide that chemotherapy before or after surgery is right for you. Past hormone treatment to help prevent cancer is allowed.
  • Group 1: Your cancer must not be HER2-positive. You may receive chemotherapy before or after surgery.
  • Group 2: You must have triple-negative breast cancer, which lacks certain hormone receptors and HER2. You must have received at least one dose of carboplatin and paclitaxel before surgery, with or without pembrolizumab.
  • Blood tests must show enough infection-fighting cells and platelets, which help blood clot. Kidney and liver tests must meet the study’s limits.
  • You or your legal representative must sign a form showing that you understand the study and agree to join.

Who can't join

  • Stage IV breast cancer, meaning cancer that has spread to distant parts of the body.
  • A high CARG risk score or a frailty score of 4 or more, as measured by the study’s assessment.
  • HER2-positive breast cancer, with a test result of 3+ or extra copies of the HER2 gene.
  • The listing says, “No prior chemotherapy within 1 year of study enrollment.” Ask the study team to explain this rule, since its wording is unclear.
  • Group 2: You cannot receive pembrolizumab during dose-dense CMF treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (7)

NJ

NY