GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT01918306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase Ib/II Trial of GDC-0941 (a PI3K Inhibitor) in Combination With Cisplatin in Patients With Androgen Receptor Negative Triple Negative Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01918306
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Interventions
- cisplatin Drug
- laboratory biomarker analysis Other
- pharmacological study Other
- dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI Procedure
- GDC -0941 Drug
Drug · Other · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2013 (Type not available)
- Primary completion
- Dec 2014 (Actual)
- Completion
- Apr 2015 (Actual)
- Last update posted
- Jun 27, 2017
2013 – 2015
United States locations
- U.S. sites
- 16
- U.S. states
- 16
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | — | — |
| University of California, San Francisco | San Francisco | California | — | — |
| Georgetown University | Washington D.C. | District of Columbia | — | — |
| Emory University | Atlanta | Georgia | — | — |
| University of Chicago | Chicago | Illinois | — | — |
| Indiana University | Indianapolis | Indiana | — | — |
| John Hopkins University | Baltimore | Maryland | — | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | — | — |
| University of Michigan | Ann Arbor | Michigan | — | — |
| Mayo Clinic | Rochester | Minnesota | — | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | — | — |
| University of North Carolina | Charlotte | North Carolina | — | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | — | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Baylor Breast Center | Houston | Texas | — | — |
| University of Washington | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01918306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 27, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01918306 live on ClinicalTrials.gov.