HER2-negative metastatic breast cancer untreated with chemotherapy
Conditions
Interventions
Nivolumab+Paclitaxel+Bevacizumab
Sponsors
Coordinating committee for WJOG 9917B investigator-initiated clinical study
West Japan Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed invasive breast carcinoma. 2)Age of >= 20 years. 3)Women. 4)Patients who are confirmed to be HER2-negative (for IHC 2+, negative being confirmed by the FISH/DISH method). 5)Patients with advanced metastatic breast cancer or inoperable recurrent breast cancer. 6)Chemotherapy-naive patients. 7)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 8)Patients with a measurable lesion based on the Response Evaluation Criteria in Solid Tumors Revised RECIST guideline version 1.1 (RECIST) in imaging assessed within 28 days prior to the enrollment. 9)A laboratory test performed within 14 days prior to the enrollment meets the following Items: - Neutrophil count=>1500/mm3 - Platelet count=>10x10000/mm3 - Hemoglobin=>8.0g/dL - AST(GOT)<=100IU/L (If patients have liver metastasis, <=200IU/L) - ALT(GPT)<=100IU/L (If patients have liver metastasis, <=200IU/L) - Total bilirubin<=1.5mg/dL - Creatinine<=1.5mg/dL - Meeting either of the followings: a) Urine protein (test strip) is negative (-) or 1+ b) In the case of urine protein (test strip) is =>2+, 24-hour urine protein should be measured, and urine protein is <=1g/24hrs 10)Well controlled blood pressure (systolic blood pressure of 150mmHg and diastolic blood pressure of 90mmHg controlled by 2 antihypertensives). 11)Life expectancy of > 3 months 12)Written consent signed personally by the patient is obtained after receiving an adequate explanation on the details of the study prior to enrollment in this clinical study. 13)For women of childbearing potential: agreement to remain abstinent and not to breastfeed from the consent of enrollment to at least 5 months after the last dose of drugs.
Exclusion criteria
Exclusion criteria: 1)Patients treated with drug therapy targeting anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CTLA-4 antibodies or other T-cell co-stimulatory receptors. 2)Patients with a history of infiltrative malignancies within the last 5 years. 3)Patients received taxane chemotherapy within the last 6 months. 4)Patients with metastases to bone only. 5)Patients received molecular targeted therapy or radiotherapy within 14 days before enrollment. 6)Patients received another investigational treatment within 28 days before enrollment. 7)Patients received a live vaccine within 30 days before the first dose of the study drug. 8)Patients required treatment with systemic corticosteroids at a predonine equivalent dose of > 10mg/day or immunosuppressive drugs for active autoimmune disease within 28 days prior to enrollment. 9)Patients with active infection requiring systemic treatment. 10)Patients with concurrent interstitial lung disease/pneumonitis or a history of interstitial lung disease/pneumonitis requiring treatment with systemic corticosteroids. 11)Patients who are pregnant or possibly pregnant or breastfeeding. 12)Patients with HBs antigen-positive or HCV antibody-positive. 13)Patients who are either HIV-1 or HIV-2 antibody-positive. 14)Patients with major cardiovascular disease. Patients with myocardial infarction or acute coronary artery disease, or underwent coronary angioplasty, stenting or bypass surgery within the last 6 months. Patients with NYHA class III to IV congestive heart failure. 15)History of disease or underlying condition: - uncontrolled diabetes - peripheral neuropathy (Grade=>2) - congenital bleeding diathesis or coagulation disorders - arterial thrombosis or venous thrombosis before 6 months from the enrollment - gastrointestinal tract perforation - active peptic ulcer disease or bleeding (Grade =>3) - other serious conditions such as renal failure or liver failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, disease control rate (DCR), progression free survival (PFS), overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactYukinori Ozaki
The Cancer Institute Hospital Of JFCR Breast Oncology Center
Outcome results
None listed