A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:September 26, 2016
End Date:November 24, 2020

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A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy

This Phase II, double-blind, randomized, placebo-controlled multicenter study will
investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab
or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC
who have received prior trastuzumab and taxane based therapy, either alone or in combination,
and/or who have progressed within 6 months after completing adjuvant therapy.


Inclusion Criteria:

- Archival tumor samples must be obtained from primary and/or metastatic sites

- Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1)
expression

- HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified
by in-situ hybridization as defined by a ratio of greater than or equal to (>=) 2.0
for the number of HER2 gene copies to the number of chromosome 17 copies

- Histologically or cytologically confirmed invasive BC: incurable, unresectable,
locally advanced BC previously treated with multimodality therapy or metastatic BC

- Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic
settings; which must include both, a taxane and trastuzumab (alone or in combination
with another agent)

- Progression must have occurred during or after most recent treatment for locally
advanced/metastatic BC or within 6 months after completing adjuvant therapy

- Participants must have measurable disease that is evaluable as per RECIST v1.1

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and
for women less than 12 months after the onset of menopause

- Use of highly effective method of contraception as defined by the protocol

Exclusion Criteria:

- Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists,
anti-programmed death-1, or anti-PD-L1 therapeutic antibody or pathway-targeting
agents

- Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days
prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior
to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other
eligibility criteria

- Radiation therapy within 2 weeks prior to Cycle 1, Day 1

- History of exposure to the cumulative doses of anthracyclines

- History of other malignancy within the previous 5 years, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine
cancer, or participants who have undergone potentially curative therapy with no
evidence of disease and are deemed by the treating physician to be at low risk for
recurrence

- Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or
ascites

- Participants with severe infection within 4 weeks prior to randomization, including
but not limited to hospitalization for complications of infection, bacteremia, or
severe pneumonia

- Current severe, uncontrolled systemic disease

- Major surgical procedure or significant traumatic injury within 28 days prior to
randomization or anticipation of the need for major surgery during the course of study
treatment

- Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with
human immunodeficiency virus, hepatitis B virus, or hepatitis C virus

- Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an
equivalent dose of other anti-inflammatory corticosteroids)

- Spinal cord compression not definitively treated with surgery and/or radiation, or
previously diagnosed and treated spinal cord compression without evidence that disease
has been clinically stable for greater than (>) 2 weeks prior to randomization

- Participants with known central nervous system disease

- Leptomeningeal disease

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplantation

- Active tuberculosis

- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or
anticipation that such a live, attenuated vaccine will be required during the study

- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of
the drug (whichever is shorter) prior to randomization

- Treatment with systemic corticosteroids or other systemic immunosuppressive
medications within 2 weeks prior to randomization, or anticipated requirement for
systemic immunosuppressive medications during the trial

- Participants who are breastfeeding, or intending to become pregnant during the study
We found this trial at
24
sites
Farmington, New Mexico 87401
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Aurora, Colorado 80045
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Baltimore, Maryland 21205
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Chattanooga, Tennessee 37404
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Columbus, Ohio 43210
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Fort Worth, TX
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Hollywood, Florida
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Kogarah, New South Wales 2217
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Minneapolis, Minnesota 55407
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3700 Saint Charles Avenue
New Orleans, Louisiana 70115
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New York, NY
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Orange, California 92868
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801 North Flamingo Road
Pembroke Pines, Florida 33028
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Pittsburgh, Pennsylvania 15213
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1201 5th Avenue North
Saint Petersburg, Florida 33719
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2100 Webster Street
San Francisco, California 94115
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Tucson, AZ
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Tucson, Arizona 85745
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York, Pennsylvania 17403
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York, PA
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