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)

NCT02915744 Phase 3 COMPLETED Results posted

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

Details

Lead sponsor	Nektar Therapeutics
Phase	Phase 3
Status	COMPLETED
Enrolment	178
Start date	2016-11
Completion	2020-07

Conditions

• Metastasis
• Breast Cancer

Interventions

• NKTR-102
• Eribulin
• Ixabepilone
• Vinorelbine
• Gemcitabine
• Paclitaxel
• Docetaxel
• Nab-paclitaxel

Primary outcomes

• Overall Survival (OS) of Patients — Within 3 years from study start
  To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.

Countries

United States, Australia, Belgium, Canada, France, Israel, Italy, Portugal, Spain, United Kingdom