A Pilot Dose Escalation Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study
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Keep this study
Lead
Hospices Civils de Lyon
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years,
ECOG performance status ≤ 2
Diagnosed with metastatic HER2-negative hormone-resistant chemotherapy-naive breast cancers, previous adjuvant chemotherapy treatment are allowed.
Histologically or cytologically proven breast cancer metastases or associated with CA 15-3 levels 50% above the normal value
Hormone resistance defined by the presence of negative hormone receptors or disease progression within 6 months of the initiation of hormone therapy.
Adequate renal and liver function (ASAT and ALAT \< twice the upper limit normal value (ULN) if no liver metastases, or \< 4×ULN if liver metastases; total bilirubin \< 2×ULN),
Adequate cardiac function (left ventricular ejection fraction (LVEF) \> 50%),
Neutrophils ≥ 1200/mm3
Platelets ≥ 105/mm3
You may not be if
Cerebral metastases and meningeal involvement,
Other malignant diseases,
Significant comorbidities,
Previous chemotherapy for metastatic disease, or previous chemotherapy with a total cumulative dose greater than 600 mg/m² for EPI or greater than 450 mg/m² for DTX
Clareo Health | A Pilot Dose Escalation Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study
