Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

February 12, 2015

Primary Completion Date

April 11, 2024

Study Completion Date

August 1, 2024

Conditions
Breast CancerBreast CarcinomaBreast TumorsMalignant Neoplasm of Breast
Interventions
DRUG

Paclitaxel

either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)

DRUG

Alisertib

40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle

Trial Locations (1)

Unknown

22 Sites, Including Dallas and Austin

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

US Oncology Research

INDUSTRY