Adenocarcinoma of the BreastPhase 2NCT07768436
A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
A Phase 2 study testing CMF Regimen and Paclitaxel in people with Adenocarcinoma of the Breast and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Adenocarcinoma of the Breast, Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- CMF Regimen and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Aug 2026to 11 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Pamela Drullinsky, MD, 516-559-1521
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Pamela Drullinsky, MD, 516-559-1521
- Recruiting
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Pamela Drullinsky, MD, 516-559-1521
- Recruiting
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Pamela Drullinsky, MD, 516-559-1521
- Recruiting
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Pamela Drullinsky, MD, 516-559-1521
- Recruiting
Memorial Sloan-Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Pamela Drullinsky, MD, 516-559-1521, drullinp@mskcc.org
- Recruiting
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Pamela Drullinsky, MD, 516-559-1521
About this study
Official title: 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.
- Being tested
- CMF Regimen, Paclitaxel
- Keywords
- adenocarcinoma of the breast, breast cancer, triple negative breast cancer, Memorial Sloan Kettering Cancer Center, 26-303
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMF RegimenDrug
CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil
PaclitaxelDrug
Paclitaxel will be administered as an IV infusion into a peripheral or central vein.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: CMF Regimen; Drug: 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 Receives: Drug: CMF Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start11 Aug 2026
- Primary completion11 Aug 2030 (estimated)
- Study completion11 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the BreastStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Drullinsky, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768436
- Sponsor's protocol ID
- 26-303
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07768436
- Acronym / sponsor ID
- 26-303
- Keywords
- adenocarcinoma of the breast, breast cancer, triple negative breast cancer, Memorial Sloan Kettering Cancer Center, 26-303
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 11 Aug 2030 (estimated)
- Study completion
- 11 Aug 2030 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CMF Regimen, Drug: PaclitaxelddCMF 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 |
| Cohort 2 | Experimental | Drug: CMF RegimenddCMF x 4 Cycles in the neoadjuvant setting, in participants who have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMF RegimenCMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil | Drug | Cohort 1, Cohort 2 |
| PaclitaxelPaclitaxel will be administered as an IV infusion into a peripheral or central vein. | Drug | Cohort 1 |
Primary outcome
Number of participants who have completed all four cycles of CMF
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela Drullinsky, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMF Regimen and Paclitaxel in people with Adenocarcinoma of the Breast and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Drullinsky, MD (516-559-1521, drullinp@MSKCC.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have completed all four cycles of CMF (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.