A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Breast Cancer
Interventions
DRUG

Bevacizumab

Bevacizumab will be administered IV at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.

DRUG

Pictilisib

Pictilisib will be administered PO QD on escalating doses.

DRUG

Letrozole

Letrozole will be administered PO at a dose of 2.5 mg QD for for each 28-day cycle.

DRUG

Paclitaxel

Paclitaxel will be administered IV at a dose of 90 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.

DRUG

Trastuzumab

Trastuzumab will be administered IV at a dose of 2-4 mg/kg on on Days 1, 8, 15, and 22 of each 28-day cycle.

Trial Locations (5)

3000

Leuven

20133

Milan

37232

Nashville

61615

Peoria

02115

Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT00960960 - A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter