Breast cancer
Conditions
Interventions
Eribulin 1.4mg/m2 (day 1, 8) /q3wks x 4 courses, followd by FEC (cyclophosphamide/epirubicin/5-fluorouracil 500/100/500mg/m2/q3wks) x 4 courses
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Disease Characteristics 1) Previously untreated, histological confirmation of invasive breast cancer. 2) Clinical stage II and IIIA Patients with a tumor size; > 2.0 cm dimension by imaging test, or < 2.0 cm with axillary lymph node metastasis clinically diagnosed as positive, are eligible. 3) Histological confirmation of breast cancer without overexpression of HER2. 4) Histological confirmation of hormonal receptor-negative breast cancer (Allred Proportion Score < 1, or J-Score <1 in the IHC test for estrogen receptor and progesterone receptor). Patient's Characteristics 1) Age of 20 and over years old. 2) PS (ECOG) 0 - 1 3) Patients with the following values in their latest laboratory tests - Neutrophil count >1,500/m3 - Platelet count > 100,000/m3 - Serum AST/ALT < 100 IU/L - Total bilirubin < 1.5 mg/dL - Serum creatinine < 1.2 mg/dL -ECG Normal or minimal changes not requiring treatment 4) Written informed consent was obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant 2) Patients with active infection 3) Patients with respiratory failure requiring oxygen inhalation therapy 4) Patients with signs or symptoms of interstitial pneumonia or pulmonary fibrosis 5) Patients who are HBs antigen-positive, HCV antibody-positive and/or HIV antibody-positive 6) Patients with diabetes mellitus associated with poor glycemic control 7) Patients with psychiatric illness that would prevent informed consent 8) Patients with history of allergy to eribulin mesylate, epirubicin hydrochloride, fluorouracil or cyclophosphamide hydrate 9) Patients with cancer within five years, not including breast cancer and lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy 10) Patients with a history of invasive breast cancer 11) Prior treatment with Epirubicin Hydrochloride >500mg/m2 12) Patients who have a previous and concurrent inflammatory breast cancer 13) Patients otherwise considered ineligible for enrollment in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate, which is defined as the absence of viable invasive tumor in both the breast and the axillary nodes, or residual ductal carcinoma in situ (DCIS) in breast and no viable invasive tumor in the axillary nodes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinical response rate 2) Disease-free survival 3) Breast-conservation rate 4) Adverse events | — |
Countries
Japan
Contacts
Public ContactTomomi Hata
National Cancer Center Center for Research Administration and Support Research Management Section Research Coordination Division
Outcome results
None listed