Can a lighter chemo combo spare older breast cancer patients?
NCT ID NCT07768436
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This study asks whether a dose-dense chemotherapy combination called CMF (cyclophosphamide, methotrexate, and fluorouracil) can be a practical alternative to the standard AC regimen (doxorubicin and cyclophosphamide) for people aged 70 and older with early-stage breast cancer. The trial will enroll 76 participants to see if they can complete all four planned cycles of CMF. The goal is to find a treatment that is easier for older adults to tolerate while still effectively controlling the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A chemotherapy regimen combining cyclophosphamide, methotrexate, and fluorouracil (CMF), given in a dose-dense schedule, compared with the standard AC regimen (doxorubicin and cyclophosphamide).
- What this could lead to
- If feasible, this could offer older adults with early-stage breast cancer a chemotherapy option that is easier to complete, potentially reducing side effects while maintaining effectiveness.
- What could go wrong
- This is a small phase 2 trial, so results may not apply broadly. The CMF regimen may still cause significant side effects, and feasibility does not guarantee long-term cancer control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan-Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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