NCT01901146

Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer

A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared With Trastuzumab in Subjects With HER2 Positive Early Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 725 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	ABP 980	ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
DRUG	Trastuzumab	Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
DRUG	Paclitaxel	Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).
PROCEDURE	Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection

Timeline

• Start date: 2013-04-29
• Primary completion: 2016-05-05
• Completion: 2017-01-27
• First posted: 2013-07-17
• Last updated: 2019-08-07
• Results posted: 2019-08-07

Locations

98 sites across 18 countries: Belarus, Brazil, Bulgaria, Canada, Chile, Germany, Greece, Hungary, Italy, Mexico, Poland, Romania, Russia, Serbia, South Africa, Spain, Ukraine, United Kingdom