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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:September 30, 2014
End Date:July 31, 2019

Use our guide to learn which trials are right for you!

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

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.


Inclusion Criteria:

- Histologically documented triple-negative adenocarcinoma of the breast that is
inoperable locally advanced or metastatic and is not amenable to resection with
curative intent

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor
specimen, required prior to randomization

- Measurable disease, according to the RECIST v1.1

- Adequate hematologic and organ function within 14 days before the first study
treatment

- For female participants of childbearing potential, agreement (by both participant and
partner) to use an effective form of contraception for the duration of the study and
for 6 months after last dose of study treatment

Exclusion Criteria:

- Any previous therapy, including chemotherapy or hormonal or targeted therapy, for
inoperable locally advanced or metastatic triple-negative adenocarcinoma of the
breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy
and/or radiation treatment for locally advanced triple negative adenocarcinoma,
provided all treatments were completed greater than or equal to (>/=) 6 months prior
to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with
curative intent

- Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1

- Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor
(ER) positive, or progesterone receptor (PR) positive breast cancer

- Previous therapy with Akt, PI3K, and/or mTOR inhibitors

- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days
prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during
the course of the study

- Known presence of the brain or spinal cord metastasis, as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or
prior radiographic assessments
We found this trial at
26
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
?
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
Athens, Georgia 30607
?
mi
from
Athens, GA
Click here to add this to my saved trials
55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
?
mi
from
Boston, MA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
101 Avenue du Laerbeek
Brussel, 1090
?
mi
from
Brussel,
Click here to add this to my saved trials
Charleston, South Carolina 29403
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
4004 North Ocean Boulevard
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Hollywood, Florida
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
11311 Bridgeport Way Southwest
Lakewood, Washington 98499
?
mi
from
Lakewood, WA
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Ogden, Utah 84403
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Luis Obispo, California 93401
?
mi
from
San Luis Obispo, CA
Click here to add this to my saved trials
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
?
mi
from
Wichita, KS
Click here to add this to my saved trials