Clinical trial · Interventional
A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer
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
NCT07768436CI-TRIAL-00122294recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Breast | Breast Adenocarcinoma | ALIAS | 0.90 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMF Regimen | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 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
- interventionNames
- Drug: CMF Regimen
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- ddCMF x 4 Cycles in the neoadjuvant setting, in participants who have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab
- interventionNames
- Drug: CMF Regimen
Primary outcomes (1)
- measure
- Number of participants who have completed all four cycles of CMF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.