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

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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
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269 Campus Drive
Stanford, California 94305
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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...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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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...
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Bronx, NY
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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...
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Albany, New York 12206
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3851 Piper Street
Anchorage, Alaska 99508
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Aurora, Colorado 80014
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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...
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401 North Broadway
Baltimore, Maryland 21287
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701 Ostrum Street
Bethlehem, Pennsylvania 18015
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330 Brookline Avenue
Boston, Massachusetts 02215
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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...
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Bristol, Tennessee 37620
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4221 Avenida Hipólito Yrigoyen
Buenos Aires, C1212ACA
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1653 West Congress Parkway
Chicago, Illinois 60612
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Cincinnati, Ohio 45242
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
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4100 John R Street
Detroit, Michigan 48201
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Fairfax, Virginia 22031
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Farmington, New Mexico 87401
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Fayetteville, Arkansas 72703
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3840 Broadway
Fort Myers, Florida 33901
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Germantown, Tennessee 38138
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Greenbrae, California 94904
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Greenville, South Carolina 29605
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30 Prospect Avenue
Hackensack, New Jersey 07601
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200 Technology Drive
Hooksett, New Hampshire 03106
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Houston, Texas 77030
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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...
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Jackson, Mississippi 39202
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
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Knoxville, Tennessee 37920
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2390 West Congress Street
Lafayette, Louisiana 70506
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Lake Success, New York 11042
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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4306 Alton Road
Miami Beach, Florida 33140
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Nashville, Tennessee 37212
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333 Cedar Street
New Haven, Connecticut 06520
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Norwalk, Connecticut 06856
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Oakland, California 94612
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Pittsburgh, Pennsylvania 15213
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Plantation, Florida
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3550 North Interstate Avenue
Portland, Oregon 97227
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Portland, Oregon 97213
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101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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7000 Boulder Avenue
Redlands, California 92373
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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...
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9905 Medical Center Drive
Rochville, Maryland 20850
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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...
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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1600 Divisadero Street
San Francisco, California 94115
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San Marcos, California 92078
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Santa Ana, California 92705
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Scottsdale, Arizona 85258
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Shreveport, Louisiana
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Spokane, Washington 99218
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Stamford, Connecticut 06904
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Tucson, Arizona 85745
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Vancouver, Washington 98684
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2811 Tieton Drive
Yakima, Washington 98902
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