NCT07768436

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
47mo left

Started Aug 2026

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Aug 2026Aug 2030

Study Start

First participant enrolled

August 11, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2030

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

4 years

First QC Date

August 12, 2026

Last Update Submit

August 12, 2026

Conditions

Adenocarcinoma of the BreastBreast CancerTriple Negative Breast Cancer

Keywords

adenocarcinoma of the breastbreast cancertriple negative breast cancerMemorial Sloan Kettering Cancer Center26-303

Outcome Measures

Primary Outcomes (1)

  • Number of participants who have completed all four cycles of CMF

    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

Study Arms (2)

Cohort 1

EXPERIMENTAL

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 RegimenDrug: Paclitaxel

Cohort 2

EXPERIMENTAL

ddCMF x 4 Cycles in the neoadjuvant setting, in participants who have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab

Drug: CMF Regimen

Interventions

CMF RegimenDRUG

CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil

Cohort 1Cohort 2
PaclitaxelDRUG

Paclitaxel will be administered as an IV infusion into a peripheral or central vein.

Cohort 1

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)
  • +4 more criteria

You may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

CMF regimenPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Pamela Drullinsky, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Drullinsky, MD

CONTACT

516-559-1521drullinp@MSKCC.ORG

Koshy Alexander, MD, MBA

CONTACT

646-888-3659alexandk@mskcc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 17, 2026

Study Start

August 11, 2026

Primary Completion (Estimated)

August 11, 2030

Study Completion (Estimated)

August 11, 2030

Last Updated

August 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)