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RecruitingBreast Cancer

BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: University of Illinois at Chicago

You may qualify if…

  • ✓ I• Age ≥ 18 years of age at time of consent
  • ✓ ECOG performance status 0, 1, or 2
  • ✓ Histologically confirmed invasive breast cancer documented by biopsy or surgical excision.
  • ✓ Underwent potentially curative resection of primary breast tumor(s) with no gross residual local-regional disease (patients with microscopically positive margins are eligible if adjuvant radiotherapy is planned), with most recent breast or axillary surgery \< 90 days prior to date of signed consent.
  • ✓ No evidence of distant metastatic disease
  • ✓ No prior systemic therapy for this cancer other than pre-operative endocrine therapy
  • ✓ Treating Oncologist recommends adjuvant chemotherapy without concurrent biologic/targeted therapy. Patients may receive a CDK4/6 inhibitor after completion of all study treatment, concurrently with adjuvant endocrine therapy. 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.
  • ✓ Tumor is estrogen receptor (ER)-positive (\> 10% by IHC) and/or progesterone receptor (PR)-positive (\> 10% by IHC), HER2-negative by IHC or FISH according to 2018 ASCO-CAP guidelines.

You may not qualify if…

  • ✕ Subjects meeting any of the criteria below are ineligible for this study:
  • ✕ Prior cytotoxic chemotherapy for this breast cancer
  • ✕ Any investigational agents administered during or within 2 weeks prior to start of CMC chemotherapy
  • ✕ AJCC stage IIIB-IIIC or stage IV
  • ✕ Active infection requiring systemic therapy
  • ✕ Untreated HIV/AIDS
  • ✕ Documented DYPD deficiency
  • ✕ Pregnant or nursing

Where it's recruiting

Illinois

Chicago

Source: ClinicalTrials.gov · NCT06085742 · last updated 2025-12-19

BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer · TrialPath