NCT02915744|CompletedPhase 3ResultsDMC

A Study of Etirinotecan Pegol (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

Nektar Therapeutics ClinicalTrials.gov

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1 other identifier

15-102-14

Study Type

interventional

Target

178

Locations

10 countries

Sites

Timeline

RegisteredSep 2016

StartedNov 2016

CompletionJul 2020

Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

178

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Nov 2016

Typical duration for phase_3

Geographic Reach

10 countries

56 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

First Submitted

Initial submission to the registry

September 22, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed

1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 27, 2021

Completed

Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

3.7 years

First QC Date

September 22, 2016

Results QC Date

July 6, 2021

Last Update Submit

April 10, 2023

Conditions

Metastasis Breast Cancer

Keywords

Breast Cancer Brain Metastases (BCBM)Carcinoma

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS) of Patients
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.
Within 3 years from study start

Secondary Outcomes (11)

Progression-Free Survival (Outside the Central Nervous System)
Through study completion, an expected average of 1 year
Progression-Free Survival in Brain Metastasis (PFS-BM)
Through study completion, an expected average of 1 year
Progression-Free Survival (Overall)
Through study completion, an expected average of 1 year
Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC)
Through study completion, an expected average of 1 year
Clinical Benefit Rate (CBR)
For at least 4 months, with an expected average of 1 year
+6 more secondary outcomes

Study Arms (2)

NKTR-102

EXPERIMENTAL

In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.

Drug: NKTR-102

Treatment of Physician's Choice (TPC)

ACTIVE COMPARATOR

In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.

Drug: EribulinDrug: IxabepiloneDrug: VinorelbineDrug: GemcitabineDrug: PaclitaxelDrug: DocetaxelDrug: Nab-paclitaxel