GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

April 30, 2015

Conditions
Estrogen Receptor Negative Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastTriple Negative Breast CancerRecurrent Breast CancerStage IV Breast CancerTriple-negative Breast Cancer
Interventions
DRUG

cisplatin

"In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~\--------------------------------------------------------------------------------"

OTHER

laboratory biomarker analysis

correlative studies

OTHER

pharmacological study

correlative studies

PROCEDURE

dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI

correlative studies

DRUG

GDC -0941

Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Trial Locations (16)

37232

Vanderbilt-Ingram Cancer Center, Nashville

Unknown

University of Alabama, Birmingham

University of California, San Francisco, San Francisco

Georgetown University, Washington D.C.

Emory University, Atlanta

University of Chicago, Chicago

Indiana University, Indianapolis

John Hopkins University, Baltimore

Dana Farber Cancer Institute, Boston

University of Michigan, Ann Arbor

Mayo Clinic, Rochester

Memorial Sloan-Kettering Cancer Center, New York

University of North Carolina, Charlotte

University of Pittsburgh, Pittsburgh

Baylor Breast Center, Houston

University of Washington, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Genentech, Inc.

INDUSTRY

lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter