NCT00456846

First Line Therapy for Patients With Metastatic Breast Cancer

An Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients With Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Celgene · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m\^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.

Detailed description

This is an open-label, phase II study to determine the toxicity and antitumor activity of ABI-007 100 mg/m2 administered weekly for 3 weeks followed by a rest week (4-week cycle) as first line therapy to patients with metastatic breast cancer in the following 2 cohorts: Patients who have received a taxane as part of their adjuvant therapy, and patients who did not receive a taxane as part of their adjuvant therapy. Patients will be assessed for antitumor response every 8 weeks. The last subject received study treatment 11DEC2012. The study was terminated on 31 May 2013 via a notification letter to all investigators on 14 May 2013.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	ABI-007	100 mg/m\^2 ABI-007 weekly for 3 weeks followed by 1 week rest

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-12-11
• Completion: 2013-05-31
• First posted: 2007-04-05
• Last updated: 2019-11-22
• Results posted: 2014-07-18

Locations

14 sites across 1 country: Canada