A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:August 2, 2018
End Date:December 29, 2024
Contact:Reference Study ID Number: WO39391 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab
in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or
epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed
by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in
patients with Stage II-III TNBC (Triple Negative Breast Cancer)


Inclusion Criteria:

- Non-metastatic operable Stage II-III breast cancer

- Histologically documented TNBC (Triple Negative Breast Cancer)

- Confirmed tumor PD-L1 evaluation as documented through central testing of a
representative tumor tissue specimen

- Adequately excised: Patients must have undergone either breast-conserving surgery or
mastectomy/nipple- or skin-sparing mastectomy

- Adequate hematologic and end-organ function

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive measures

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures and agreement to refrain from donating sperm.

- No more than 8 weeks (56 days) may elapse between definitive breast surgery and
randomization.

- Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical
resection in paraffin blocks (preferred) or at least 25 unstained slides.

Exclusion Criteria

- Prior history of invasive breast cancer

- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment
(e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy,
anti-HER2 therapy.

- Previous therapy with anthracyclines or taxanes for any malignancy

- Cardiopulmonary dysfunction

- Prior malignancies within 5 years prior to randomization, with the exception of those
with a negligible risk of metastasis or death and treated with expected curative
outcome

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan

- Urinary outflow obstruction

- Active tuberculosis

- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation
of study treatment or anticipation of need for a major surgical procedure during study
treatment or within 5 months following the last dose of Atezolizumab (for patients
randomized to Atezolizumab)

- Prior allogeneic stem cell or solid organ transplant

- Treatment with systemic immunosuppressive medications within 2 weeks prior to
initiation of study treatment or anticipation of need for systemic immunosuppressive
medication during the study
We found this trial at
31
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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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...
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Alexandria, Louisiana 71301
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22 South Greene Street
Baltimore, Maryland 21201
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Baltimore, MD
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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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Berazategui,
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90 Poly Drive
Billings, Montana 59101
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Chicago, IL
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Concord, California 94520
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Concord, CA
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300 East Locust Street
Des Moines, Iowa 50309
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Des Moines, IA
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Edina, MN
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Fort Worth, TX
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Goldsboro, North Carolina 27534
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Goldsboro, NC
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200 Technology Drive
Hooksett, New Hampshire 03106
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Hooksett, NH
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Huntington, West Virginia 25702
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Huntington, WV
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Jacksonville, Florida 32207
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100 Mercy Way
Joplin, Missouri 64804
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Kansas City, Missouri 64132
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450 Lakeville Rd
Lake Success, New York 11040
(516) 734-8900
Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
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Lake Success, NY
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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Marietta, GA
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Nashville, Tennessee 37203
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Paramus, New Jersey 07450
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Paramus, NJ
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Rapid City, SD
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Rochester, NY
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Saint George, UT
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Saint Helena, California 94574
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Saint Helena, CA
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Towson, MD
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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...
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Wichita, KS
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