Breast cancer metastic brain tumor
Conditions
Interventions
One cycle of concomitant eribulin administration with 2.5 Gy*15 doses of radiation (37.5 Gy).
Eribulin (0.7-1.4 mg/m2) should be administered on day 1, and the second dose should be administered on da
Sponsors
Miki Shunichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with advanced breast cancer metastatic brain tumors who are not eligible for surgery or stereotactic radiotherapy (SRS/SRT) 2) Expected to survive at least 3 months after study entry 3) Age between 18 and 80 years at the time of consent 4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 5) Patients with no history of whole-brain irradiation. 6) Patients who maintain the function of main organs as follows: Neutrophil count > 1000/uL Lymphocyte count > 500/uL Platelet count > 75.000/uL Hemoglobin > 9g/dL AST 50mL/min (Cockcroft-Gault formula) Non-hematologic toxicity; CTCAE Grade 2 or less (but not alopecia, peripheral neuropathy Grade 3 or less, and any other toxicity that the investigator deems not to be a safety risk for the patient) Non-hematologic toxicity; CTCAE Grade 2 or less (excluding alopecia, peripheral neuropathy Grade 3 or less, and other toxicities that the investigator determines pose no safety risk to the patient) 7) Patients or the representative who have been fully informed of the study and have given their informed and voluntary written consent to participate.
Exclusion criteria
Exclusion criteria: 1) Patients who have undergone major surgery, chemotherapy, radiation therapy, or other anticancer therapy within 7 days prior to the start of treatment (or enrollment) 2) Have or are suspected to have an active infectious disease 3) Patients with severe major organ complications (cardiac disease, liver cirrhosis, uncontrolled hypertension/diabetes, bleeding tendency, etc.) 4) Patients with the following history within 180 days of registration myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class III or IV heart failure according to NYHA classification 5) HBs antigen positive 6) Pregnant, lactating, or possibly pregnant 7) Received any other study or investigational drug within 3 months prior to this study treatment. 8) Has a history of serious drug hypersensitivity or allergy to the study drug 9) Other conditions that make the subject unsuitable for the study as determined by the investigator (sub-investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of dose-limiting toxicities (DLTs) in combination therapy with eribulin and radiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Progression-free survival (PFS) of brain lesions Acute side effects of radiation to the head (mucositis, dermatitis, otitis media, nausea, and vomiting) Percentage of non-hematologic toxicity (CATAE Grade 3 or higher) and hematologic toxicity (Grade 4 or higher) Percentage of patients who received eribulin on day21 or day28 Percentage of patients who failed to receive eribulin on day 8 or day 15 Survival, progression-free survival, and PS changes up to 24 months post-treatment compared to historical data Cognitive function (MMSE): at start, 3 and 6 months post-treatment | — |
Contacts
Public ContactErika Yamada
University of Tsukuba Hospital
Outcome results
None listed