metastatic breast cancer
Conditions
Interventions
Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses and Docetaxel with a dose of 50-75 mg/m2 every
Sponsors
Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients recieving combination chemotherapy with Pertuzumab, Trastuzumab and Docetaxel. 2. Patients with breast cancer which is confirmed to be invasive breast cancer by histological examination. 3. Reccurent/inoperable HER2-positive breast cancer patients. 4. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods. 5. Patients with the history of Trastuzumab treatment 6. Patients with a performance status (ECOG) of 0, 1, or 2. 7. Left ventricular ejection fraction (LVEF) is equal or greater than 50% measured by cardiac ultrasonography. 8. Patients with adequately maintained organ and bone marrow functions. 9. Patients who provided written informed consent by themselves in principle to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. Male patients 2. Patients with allergy to the medicines in this protocol treatment. 3. Active infection or fever suspicious of infection. 4. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception. 5. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to strategy failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Disease free survival Response rate Safety | — |
Countries
Japan
Contacts
Public ContactHidemi Kawajiri
Osaka City University Graduate School of Medicine Department of Surgical Oncology
Outcome results
None listed