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

12. august 2026 opdateret af: Memorial Sloan Kettering Cancer Center

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

76

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • New Jersey
      • Basking Ridge, New Jersey, Forenede Stater, 07920
        • Rekruttering
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
        • Kontakt:
          • Pamela Drullinsky, MD
          • Telefonnummer: 516-559-1521
      • Middletown, New Jersey, Forenede Stater, 07748
        • Rekruttering
        • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
        • Kontakt:
          • Pamela Drullinsky, MD
          • Telefonnummer: 516-559-1521
      • Montvale, New Jersey, Forenede Stater, 07645
        • Rekruttering
        • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
        • Kontakt:
          • Pamela Drullinsky, MD
          • Telefonnummer: 516-559-1521
    • New York
      • Commack, New York, Forenede Stater, 11725
        • Rekruttering
        • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
        • Kontakt:
          • Pamela Drullinsky, MD
          • Telefonnummer: 516-559-1521
      • Harrison, New York, Forenede Stater, 10604
        • Rekruttering
        • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
        • Kontakt:
          • Pamela Drullinsky, MD
          • Telefonnummer: 516-559-1521
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan-Kettering Cancer Center (All Protocol Activities)
        • Kontakt:
      • Uniondale, New York, Forenede Stater, 11553
        • Rekruttering
        • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
        • Kontakt:
          • Pamela Drullinsky, MD
          • Telefonnummer: 516-559-1521

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: CMF Regimen
CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil
Medicin: Paclitaxel
Paclitaxel will be administered as an IV infusion into a peripheral or central vein.
Eksperimentel: Cohort 2
ddCMF x 4 Cycles in the neoadjuvant setting, in participants who have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab
Medicin: CMF Regimen
CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants who have completed all four cycles of CMF
Tidsramme: 6 months
Evaluate the feasibility of 4 cycles of ddCMF as an alternative to AC in 2 standard regimens in patients > or = to age 70 with breast cancer. Feasibility is evaluated by the completion of all four cycles of CMF.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Memorial Sloan Kettering Cancer Center

Efterforskere

  • Ledende efterforsker: Pamela Drullinsky, MD, Memorial Sloan Kettering Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. august 2026

Primær færdiggørelse (Anslået)

11. august 2030

Studieafslutning (Anslået)

11. august 2030

Datoer for studieregistrering

Først indsendt

12. august 2026

Først indsendt, der opfyldte QC-kriterier

12. august 2026

Først opslået (Faktiske)

17. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-303

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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