BREAST: METASTATIC: Stable brain mets; prior taxane, anthracycline, 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)

Title
Nektar 15-102-14
Study Title
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)
Site Link
Malignancy
Breast, Metastatic Breast Cancer, stable brain metastases, MBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd line or greater
Investigational Agent
NEKTR 102 (etirinotecan pegol)
Drug Class
pegylated pro-drug
PI
Lee Schwartzberg, MD
Sponsor
Nektar Therapeutics
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • 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

Objective
OS; Secondary- PFS, PFS in brain, ORR, CBR, DoR, Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma (any ER/PR/HER2 status)
Dosing Frequency
Control Agents
MD choice of eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, abraxane
Study Protocol
Randomized
No
X