OncoMatch/Clinical Trials/NCT06085742
BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer
Is NCT06085742 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cyclophosphamide and Methotrexate for breast cancer.
Treatment: Cyclophosphamide · Methotrexate · Capecitabine — This is a non-randomized, single arm phase 2 trial of oral CMC based on conversion of doses that would be delivered with conventional metronomic CMF chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>10% by IHC) (>10% by IHC)
Tumor is estrogen receptor (ER)-positive (> 10% by IHC)
Required: PR (PGR) overexpression (>10% by IHC) (>10% by IHC)
Tumor is progesterone receptor (PR)-positive (> 10% by IHC)
Required: HER2 (ERBB2) negative by IHC or FISH according to 2018 ASCO-CAP guidelines
HER2-negative by IHC or FISH according to 2018 ASCO-CAP guidelines
Excluded: DPYD deficiency
Documented DYPD deficiency
Allowed: BRCA1 germline pathogenic/likely pathogenic variant
Patients with a germline pathogenic/likely pathogenic variant in a DNA homologous repair gene (e.g. BRCA1, BRCA2, PALB2) may receive adjuvant PARP inhibitor therapy after completion of all study treatment.
Allowed: BRCA2 germline pathogenic/likely pathogenic variant
Patients with a germline pathogenic/likely pathogenic variant in a DNA homologous repair gene (e.g. BRCA1, BRCA2, PALB2) may receive adjuvant PARP inhibitor therapy after completion of all study treatment.
Allowed: PALB2 germline pathogenic/likely pathogenic variant
Patients with a germline pathogenic/likely pathogenic variant in a DNA homologous repair gene (e.g. BRCA1, BRCA2, PALB2) may receive adjuvant PARP inhibitor therapy after completion of all study treatment.
Disease stage
Required: Stage PT1, PT2, PT3, PN0, PN1MIC, PN1, PN2, STAGE IIIA (AJCC)
Excluded: Stage IIIB, IIIC, IV
AJCC pathologic stage: pT1-3/pN0-2 based on sentinel lymph node biopsy or axillary dissection; stage IIIA (pT3/pN1 or pT1-3/pN2); Exclusion: AJCC stage IIIB-IIIC or stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy — pre-operative
No prior systemic therapy for this cancer other than pre-operative endocrine therapy
Cannot have received: cytotoxic chemotherapy
Prior cytotoxic chemotherapy for this breast cancer
Cannot have received: investigational agent
Any investigational agents administered during or within 2 weeks prior to start of CMC chemotherapy
Lab requirements
Blood counts
Must meet study eligibility criteria (see Table 1)
Kidney function
Must meet study eligibility criteria (see Table 1)
Liver function
Must meet study eligibility criteria (see Table 1)
Adequate organ function as defined in Table 1. All screening labs to be obtained within 30 days prior to registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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