A Phase 2 interventional study of CMF Regimen and Paclitaxel in Adenocarcinoma of the Breast, Breast Cancer and Triple Negative Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
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Among 10 studies in Triple Negative Breast Neoplasms by Memorial Sloan Kettering Cancer Center — 5 open to participants now, 9 under way, none of them phase 3. Triple Negative Breast Neoplasms · Memorial Sloan Kettering Cancer Center.
Among the 10 studies in Triple Negative Breast Neoplasms by Memorial Sloan Kettering Cancer Center, this one is the 4th largest by planned enrollment, is the only one that started in 2026, is one of 7 in phase 2, and was the 10th registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
Browse Triple Negative Breast Neoplasms studies →5 of the 10 studies in Triple Negative Breast Neoplasms by Memorial Sloan Kettering Cancer Center are open now, in 1 country. Recruiting first, the newest first:
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+ · Women only
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 331 Triple Negative Breast Neoplasms studies recruiting now, 231 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 70 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 76 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Median enrollment 53 across the 10 interventional studies. Of the 1 that completed or were terminated, 1 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 326 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
7 of the studies in Triple Negative Breast Neoplasms by Memorial Sloan Kettering Cancer Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03808337Memorial Sloan Kettering Cancer CenterInvestigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease | 2027-01 |
| NCT04683679Memorial Sloan Kettering Cancer CenterA Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer | 2027-01 |
| NCT03808662Memorial Sloan Kettering Cancer CenterRandomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung | 2027-01 |
| NCT06246968Memorial Sloan Kettering Cancer CenterA Study of Pembrolizumab and Ablation (Cryoablation or Histotripsy) in People With Breast Cancer | 2027-01-29 |
| NCT02750358Memorial Sloan Kettering Cancer CenterFeasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer | 2027-05 |
Add all 7 to your calendar (.ics) → With an account.
Among the 10 studies in Triple Negative Breast Neoplasms by Memorial Sloan Kettering Cancer Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
This study's planned enrollment of 76 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 326 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
Compared within Triple Negative Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Required Organ Function
Adequate hematologic function defined as follows:
Adequate renal function defined as follows:
° (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:
and ALT ≤3 x institutional ULN
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 Regimen · Drug: Paclitaxel
ddCMF x 4 Cycles in the neoadjuvant setting, in participants who have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab
Drug: CMF Regimen
CMF regimen: Cyclophosphamide, Methotrexate, and Fluorouracil
Paclitaxel will be administered as an IV infusion into a peripheral or central vein.
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.
Time frame: 6 months
Plan to share: 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.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2030, 48 months after the start.
Of 220 non-industry phase 2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 99. This study's planned 48 months is below that.
Counting every sponsor, half of 255 studies reached it within 59 months; a quarter within 37 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: CMF regimen
Triple Negative Breast Neoplasms →
Memorial Sloan Kettering Cancer Center →