Can older adults with breast cancer tolerate a dense CMF chemo schedule

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial examines dose-dense CMF (cyclophosphamide, methotrexate, and fluorouracil) in two standard regimens for patients aged 70 and above with breast cancer. It includes participants with adenocarcinoma of the breast, including triple-negative cases, and requires specific receptor testing. The study uses CMF alongside paclitaxel and is conducted at Memorial Sloan Kettering locations in New Jersey. Eligibility focuses on performance status, age, histology confirmation, and prior treatments relevant to the cohorts.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan-Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Pamela Drullinsky, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Pamela Drullinsky, MD
• Email: drullinp@MSKCC.ORG
• Phone: 516-559-1521

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using mistletoe extract with pembrolizumab for treating triple negative breast cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.