Recruiting
Phase 2

Dose-Dense CMF

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07768436

Conditions

Adenocarcinoma of the Breast

Breast Cancer

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

CMF Regimen

Paclitaxel

Study Details

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.

Conditions

Adenocarcinoma of the Breast

Breast Cancer

Triple Negative Breast Cancer

Study ID

NCT07768436

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Aug 11, 2030

Anticipated

Primary completion date

Aug 11, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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

Enrollment

76 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: Cohort 2

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

Interventions

CMF Regimen

CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil

Paclitaxel

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

Primary outcome measure

  • Number of participants who have completed all four cycles of CMF [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Pamela Drullinsky, MD

516-559-1521drullinp@MSKCC.ORG

Koshy Alexander, MD, MBA

646-888-3659alexandk@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Pamela Drullinsky, MD

516-559-1521

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Pamela Drullinsky, MD

516-559-1521

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Pamela Drullinsky, MD

516-559-1521

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Pamela Drullinsky, MD

516-559-1521

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Pamela Drullinsky, MD

516-559-1521

Memorial Sloan-Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Pamela Drullinsky, MD

516-559-1521drullinp@mskcc.org

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Pamela Drullinsky, MD

516-559-1521

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • adenocarcinoma of the breast
  • breast cancer
  • triple negative breast cancer
  • Memorial Sloan Kettering Cancer Center
  • 26-303

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-17.