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A Phase 3 open-label, randomized, multicenter study of NKTR-102 versus treatment of physician’s choice (TPC) in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine (ATTAIN)
A Phase 3 open-label, randomized, multicenter study of NKTR-102 versus treatment of physician’s choice (TPC) in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine (ATTAIN)
Any gender
Single-agent cytotoxic chemotherapy indicated
Can be measurable or non-measurable disease
Must have a history of brain metastases that are non-progressing
In TNBC, must have at least 1 prior lines of metastatic cytotoxic therapy
In non-TNBC, prior therapy as indicated is required
Have received prior therapy with anthracycline, taxane, and capecitabine in any setting (neo-adj, adj, or metastatic)
Most recent anti-cancer therapy within 6 months of randomization
ECOG PS 0-1
No prior SCT
No prior camptothecin-derived agent
No leptomeningeal disease
No HBV/HCV/HIV
No cirrhosis
No other malignancy within 5 years
No need for O2 supplementation
OS; Secondary- PFS, PFS in brain, ORR, CBR, DoR, Safety