HER2 positive advanced breast cancer
Conditions
Interventions
A: Trastuzumab (6 mg/kg, loading dose 8 mg/kg) + Pertuzumab (420 mg, loading dose 840 mg) + Docetaxel 60 mg/m2 q3w until Progression Disease (PD)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically proven breast cancer (invasive cancer). 2) Histologically proven HER2 positive. Presense/absence of overexpression of estrogen receptor (ER) was examined. 3) Advanced breast cancer with distant metastatsis. 4) Women aged 65 to 79 years old. 5) ECOG performance status (PS) of 0 or 1 for 65 to 74 years old and 0 to 2 for 75 to 79 years old. 6) A measurable lesion is not required. 7) No active brain metastasis requiring therapy. 8) Neither prior chemotherapy (cytotoxic drug) or prior anti-HER2 therapy (trastuzumab, lapatinib, pertuzumab or T-DM1) for advanced breast cancer. 9) Adequate baseline laboratory data within 14 days prior to registration: 1. neutrophil count >= 1,500 /mm3 2. hemogrobin >= 9.0mg/dL without blood transfution within 14 days 3. platelet count >= 100,000 /mm3 4. total bilirubin <= 1.5 mg/dL 5. AST <= 100 U/L 6. ALT <= 100 U/L 7. serum creatinin <= 1.2 mg/dL 10) Left ventricular ejection fraction (LVEF) >= 50% by newest cardiography 11) Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Simultaneous or metachronouss (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 2. Active infection requiring systemic therapy. 3. Body temperature of 38.0 degrees Celsius or higher. 4. Severe psychiatric diseases. 5. Patients requiring systemic steroid medication or the other immunosuppressive drug. 6. Poorly controlled diabetes mellitus. 7. Poorly controlled hypertension. 8. Unstable angina pectoris or history of myocardial infarction within 6 months. 9. Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy. 10. HBs antigen positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, cumulative breast cancer specific survival, overall response rate, adverse events, serious adverse events, proportion of non-deteriorating of instrumental activities of daily living | — |
Countries
Japan
Contacts
Public ContactAkihiko Shimomura
JCOG1607 Coordinating Office Department of Breast and Medical Oncology
Outcome results
None listed