A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:June 23, 2015
End Date:April 30, 2020

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

A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and
pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with
placebo in combination with nab-paclitaxel in participants with locally advanced or
metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy
for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been
determined in previous studies of participants with mBC and the safety data to date suggest
that atezolizumab can be safely combined with standard chemotherapy agents.


Inclusion Criteria:

- Metastatic or locally advanced, histologically documented TNBC characterized by
absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and
progesterone receptor (PR) expression

- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or
metastatic TNBC

- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression,
life-threatening visceral metastases, or the need for rapid symptom and/or disease
control)

- A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks,
or at least 20 unstained slides with an associated pathology report documenting ER,
PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at
baseline, and not fewer than 12 unstained slides will be eligible upon discussion with
Medical Monitor

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Measurable disease as defined by RECIST v1.1

- Adequate hematologic and end-organ function

Exclusion Criteria:

- Known central nervous system (CNS) disease, except for treated asymptomatic CNS
metastases

- Leptomeningeal disease

- Pregnancy or lactation

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplantation

- Positive test for human immunodeficiency virus

- Active hepatitis B or hepatitis C

- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during
treatment, or within 5 months following the last dose of atezolizumab/placebo
We found this trial at
66
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
3851 Piper Street
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Aurora, Colorado 80014
?
mi
from
Aurora, CO
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
401 North Broadway
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
701 Ostrum Street
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
330 Brookline Avenue
Boston, Massachusetts 02215
?
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
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
4221 Avenida Hipólito Yrigoyen
Buenos Aires, C1212ACA
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
1653 West Congress Parkway
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
3100 Plaza Properties Boulevard
Columbus, Ohio 43219
?
mi
from
Columbus, OH
Click here to add this to my saved trials
4100 John R Street
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Farmington, New Mexico 87401
?
mi
from
Farmington, NM
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
3840 Broadway
Fort Myers, Florida 33901
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Greenbrae, California 94904
?
mi
from
Greenbrae, 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
30 Prospect Avenue
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
200 Technology Drive
Hooksett, New Hampshire 03106
?
mi
from
Hooksett, NH
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
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
Click here to add this to my saved trials
7015 A C Skinner Parkway
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
2390 West Congress Street
Lafayette, Louisiana 70506
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
4306 Alton Road
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37212
?
mi
from
Nashville, TN
Click here to add this to my saved trials
333 Cedar Street
New Haven, Connecticut 06520
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Norwalk, Connecticut 06856
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Oakland, California 94612
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plantation, Florida
?
mi
from
Plantation, FL
Click here to add this to my saved trials
3550 North Interstate Avenue
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
Portland, Oregon 97213
?
mi
from
Portland, OR
Click here to add this to my saved trials
101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
?
mi
from
Providence, RI
Click here to add this to my saved trials
7000 Boulder Avenue
Redlands, California 92373
?
mi
from
Redlands, CA
Click here to add this to my saved trials
223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
?
mi
from
Ridgewood, NJ
Click here to add this to my saved trials
9905 Medical Center Drive
Rochville, Maryland 20850
?
mi
from
Rochville, MD
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
1201 5th Avenue North
Saint Petersburg, Florida 33705
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Marcos, California 92078
?
mi
from
San Marcos, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85258
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Shreveport, Louisiana
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Spokane, Washington 99218
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Stamford, Connecticut 06904
?
mi
from
Stamford, CT
Click here to add this to my saved trials
269 Campus Drive
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tucson, Arizona 85745
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Vancouver, Washington 98684
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
2811 Tieton Drive
Yakima, Washington 98902
?
mi
from
Yakima, WA
Click here to add this to my saved trials