A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:February 2013
End Date:June 2016
Contact:Reference Study ID Number: GO28509 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. Only)

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

A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer

This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate
the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in
patients with locally recurrent or metastatic breast cancer.


Inclusion Criteria:

- Female adult patients

- Histologically or cytologically confirmed adenocarcinoma of the breast, with
measurable or non-measurable locally recurrent or metastatic disease

- Human epidermal growth factor receptor 2 (HER2)-negative and HR (estrogen receptor
and/or progesterone receptor)-positive disease as defined by local guidelines

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

- Adequate hematologic and end organ function

- Women of childbearing potential must agree to remain abstinent or to use two adequate
methods of contraception, including at least one method with a failure rate of < 1%
per year, during the treatment period and for at least 30 days after the last dose of
study treatment or 6 months after discontinuation of paclitaxel, whichever is longer

Exclusion Criteria:

- Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease

- Prior treatment with a PI3K inhibitor for advanced or metastatic breast cancer

- History of intolerance to a taxane-containing therapy

- History of clinically significant cardiac or pulmonary dysfunction

- History of malabsorption syndrome or other condition that would interfere with
enteral absorption

- Clinically significant history of liver disease

- Active autoimmune disease or active inflammatory disease

- Immunocompromised status

- Need for current chronic corticosteroid therapy

- Pregnancy, lactation, or breastfeeding

- Current severe, uncontrolled systemic disease

- Known untreated or active central nervous system (CNS) metastases
We found this trial at
48
sites
?
mi
from
Hayward, CA
Click here to add this to my saved trials
?
mi
from
Abington, PA
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Albany, GA
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Auburn, ME
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Bedford, TX
Click here to add this to my saved trials
?
mi
from
Billings, MO
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Brookline, MA
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Edmonds, WA
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hartford, CT
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Joliet, IL
Click here to add this to my saved trials
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Oakland, CA
Click here to add this to my saved trials
?
mi
from
Ogden, UT
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Pleasant Hill, California 94522
?
mi
from
Pleasant Hill, CA
Click here to add this to my saved trials
Pleasant Hill, California 94522
?
mi
from
Pleasant Hill, CA
Click here to add this to my saved trials
?
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
San Jose, CA
Click here to add this to my saved trials
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Sedona, AZ
Click here to add this to my saved trials
?
mi
from
Sherman, TX
Click here to add this to my saved trials
South San Francisco, California 94080
?
mi
from
South San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
?
mi
from
Winchester, VA
Click here to add this to my saved trials