A Phase 2 interventional trial at Memorial Sloan Kettering Cancer Center is actively enrolling adults aged 70 and older with early-stage breast cancer to assess the feasibility of dose-dense CMF (cyclophosphamide, methotrexate, fluorouracil) as an alternative to standard AC-based (doxorubicin/cyclophosphamide) chemotherapy regimens.
Memorial Sloan Kettering Cancer Center has initiated a Phase 2 feasibility trial (NCT07768436) examining dose-dense CMF—cyclophosphamide, methotrexate, and fluorouracil—as a potential substitute for anthracycline-containing AC regimens in two standard chemotherapy frameworks for early-stage breast cancer. The trial is currently recruiting and targets individuals aged 70 years and older, a population in which anthracycline-associated cardiotoxicity and tolerability concerns are particularly relevant.
The primary objective is to determine whether dose-dense CMF administration is operationally and clinically feasible within these regimen structures. The trial also incorporates paclitaxel as part of the investigational framework, suggesting evaluation within taxane-containing sequences. Eligible diagnoses include adenocarcinoma of the breast and triple-negative breast cancer (TNBC), the latter representing a subtype with limited targeted therapy options and historically reliant on cytotoxic chemotherapy backbones.
The rationale for revisiting CMF in this context reflects growing interest in de-escalating cardiotoxic anthracycline exposure in older adults without compromising oncologic outcomes. If feasibility endpoints are met, this trial could inform the design of larger efficacy studies comparing CMF-based dose-dense strategies against AC-based standards in geriatric oncology populations. Full efficacy and safety data are not yet available given the trial's active recruiting status.
Key points
- Phase 2 trial (NCT07768436) at Memorial Sloan Kettering is recruiting adults ≥70 years with early-stage breast cancer, including TNBC.
- Dose-dense CMF (cyclophosphamide, methotrexate, fluorouracil) is being evaluated as an anthracycline-sparing alternative to AC-based regimens.
- Primary endpoint is feasibility of administering dose-dense CMF within two standard chemotherapy regimen frameworks.
- Paclitaxel is included in the investigational regimen structure, indicating evaluation within taxane-containing sequences.
- The trial addresses a critical gap in geriatric oncology, where anthracycline cardiotoxicity limits chemotherapy tolerability.
Why it matters
Older adults with early-stage breast cancer face disproportionate risk of anthracycline-related cardiac toxicity, yet evidence-based alternatives remain limited. This trial could establish the groundwork for CMF-based dose-dense regimens as a safer cytotoxic backbone in patients aged 70 and older.