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

Summary

This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K inhibitor GDC-0941 when given with the chemotherapy cisplatin. This study will also examine how well the combination of GDC-0941 and cisplatin work in treating patients with androgen receptor negative triple negative metastatic breast cancer. Patients will be randomized to receive cisplatin alone or cisplatin with GDC-0941 in the phase II portion. Those receiving cisplatin alone can receive GDC-0941 upon progression of their disease. Cisplatin is a chemotherapy which has been shown to be effective in treating triple negative breast cancer. Preclinical studies show that adding a PI3K inhibitor such as GDC-0941 to cisplatin may be a more effective treatment for breast cancer.

Conditions

• Estrogen Receptor Negative Breast Cancer
• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
• Triple Negative Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer
• Triple-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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Genentech, Inc.

  collaborator INDUSTRY

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Vandana G. Abramson, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2014-12-31

Completion

2015-04-30

Countries

• United States

Study Locations