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OncoMatch/Clinical Trials/NCT07768436

A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer

Is NCT07768436 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including CMF Regimen and Paclitaxel for adenocarcinoma of the breast.

Phase 2RecruitingMemorial Sloan Kettering Cancer CenterNCT07768436Data as of Sep 2026

Treatment: CMF Regimen · PaclitaxelThe 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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Paclitaxel

Other

CMF Regimen

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Biomarker criteria

Excluded: HER2 (ERBB2) overexpression

Her 2 Neu positive 3+/amplified breast cancer

Excluded: HER2 (ERBB2) overexpression

Cohort 1 only: Patients have any histology except Her 2 Neu positive in the adjuvant or neoadjuvant setting

Disease stage

Excluded: Stage IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≥ 70

Prior therapy

Must have received: carboplatin/paclitaxel-based chemotherapy (carboplatin, paclitaxel, pembrolizumab) — neoadjuvant

Cohort 2 only: Patients have received at least 1 dose of carboplatin/paclitaxel +/- pembrolizumab in the neoadjuvant setting

Cannot have received: chemotherapy

Exception: within 1 year of study enrollment

No prior chemotherapy within 1 year of study enrollment

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3

Kidney function

Creatinine clearance (CrCL) of >30 mL/min by the Cockcroft-Gault formula

Liver function

Total bilirubin ≤ 1.5 x institutional 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

Adequate hematologic function defined as follows: ANC ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3. Adequate renal function defined as follows: CrCL >30 mL/min by the Cockcroft-Gault formula. Adequate hepatic function defined as follows: Total bilirubin ≤ 1.5 x institutional 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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
  • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) · Middletown, New Jersey
  • Memorial Sloan Kettering at Bergen (Limited Protocol Activities) · Montvale, New Jersey
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) · Commack, New York
  • Memorial Sloan Kettering at Westchester (Limited Protocol Activities) · Harrison, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07768436 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy disqualifies patients from enrollment.

Are patients with ERBB2 alterations eligible?

No. ERBB2 overexpression is an exclusion criterion.

Are patients with ERBB2 alterations eligible?

No. ERBB2 overexpression is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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