A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
Public ClinicalTrials.gov record NCT02162719. 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.
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Official title
A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.
Study identification
- NCT ID
- NCT02162719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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
- Aug 19, 2014 (Actual)
- Primary completion
- Jun 7, 2016 (Actual)
- Completion
- Aug 31, 2019 (Actual)
- Last update posted
- Mar 10, 2021
2014 – 2019
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St Jude Heritage Medical Group | Fullerton | California | 92835 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Cancer Care Assoc Med Group | Los Angeles | California | 90095-1772 | — |
| UCLA Medical Center | Santa Monica | California | 90404 | — |
| Holycross Medical Group | Fort Lauderdale | Florida | 33308 | — |
| Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89014 | — |
| Carolinas Healthcare System | Charlotte | North Carolina | 28208 | — |
| The WEST CLINIC, P.C. | Memphis | Tennessee | 38119 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Northern Utah Associates | Ogden | Utah | 84403 | — |
| Northwest Medical Specialties | Lakewood | Washington | 98499 | — |
| West Virginia University Hospitals Inc | Morgantown | West Virginia | 26056 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02162719, 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 Mar 10, 2021 · Synced Nov 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02162719 live on ClinicalTrials.gov.