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 |
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.
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
340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
Marietta, Georgia 30060
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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4221 Avenida Hipólito Yrigoyen
Buenos Aires, C1212ACA
Buenos Aires, C1212ACA
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
Columbus, Ohio 43219
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1515 Holcombe Blvd
Houston, Texas 77030
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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7015 A C Skinner Parkway
Jacksonville, Florida 32256
Jacksonville, Florida 32256
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101 Dudley St
Providence, Rhode Island 02905
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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The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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
Saint Petersburg, Florida 33705
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1600 Divisadero Street
San Francisco, California 94115
San Francisco, California 94115
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Washington, District of Columbia 20007
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