NCT01423123 - Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

March 31, 2014

Conditions

Breast Cancer

Interventions

DRUG

Paclitaxel

80 mg/m2 IV on days 1, 8, and 15 every 28 days until disease progression.

BIOLOGICAL

trastuzumab

4 mg/kg IV loading dose, then 2 mg/kg IV weekly until disease progression.

DRUG

Neratinib

Dose level 1: 120 mg/day orally; Dose level 2: 160 mg/day orally; Dose level 3: 240 mg/day orally; Dose level 4: 200 mg/day orally.

Trial Locations (4)

NSABP Foundation, Inc., Pittsburgh

Cancer Institute of New Jersey, New Brunswick

University of Pittsburgh, Pittsburgh

West Virginia University Hospitals, Morgantown