Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer Nivolumab Evaluation With BEvacizumab And pacliTaxel (NEWBEAT) study (WJOG9917B) - Phase II study of nivolumab combination therapy for HER2-negative metastatic breast cancer (WJOG9917B)- NEWBEAT study

Coordinating committee for WJOG 9917B investigator-initiated clinical study0 sites57 target enrollmentDecember 4, 2017

ConditionsHER2-negative metastatic breast cancer untreated with chemotherapy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HER2-negative metastatic breast cancer untreated with chemotherapy
Sponsor: Coordinating committee for WJOG 9917B investigator-initiated clinical study
Enrollment: 57
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

For patients with HER2-negative metastatic breast cancer, nivolumab plus bevacizumab and paclitaxel combination therapy showed the promising efficacy and toxicities were manageable.

Registry

who.int

Start Date

December 4, 2017

End Date

October 23, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Coordinating committee for WJOG 9917B investigator-initiated clinical study

Eligibility Criteria

Inclusion Criteria

Not provided

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