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

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

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
Minneapolis, Minnesota 55407
1117
mi
from 02139
Minneapolis, MN
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
2483
mi
from 02139
Seattle, WA
Click here to add this to my saved trials
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...
927
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
1760
mi
from 02139
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 21205
355
mi
from 02139
Baltimore, MD
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
915
mi
from 02139
Chattanooga, TN
Click here to add this to my saved trials
Columbus, Ohio 43210
640
mi
from 02139
Columbus, OH
Click here to add this to my saved trials
Farmington, New Mexico 87401
2000
mi
from 02139
Farmington, NM
Click here to add this to my saved trials
4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
1246
mi
from 02139
Fort Myers, FL
Click here to add this to my saved trials
1574
mi
from 02139
Fort Worth, TX
Click here to add this to my saved trials
Hollywood, Florida
1241
mi
from 02139
Hollywood, FL
Click here to add this to my saved trials
Kogarah, New South Wales 2217
10095
mi
from 02139
Kogarah,
Click here to add this to my saved trials
940
mi
from 02139
Nashville, TN
Click here to add this to my saved trials
3700 Saint Charles Avenue
New Orleans, Louisiana 70115
1358
mi
from 02139
New Orleans, LA
Click here to add this to my saved trials
186
mi
from 02139
New York, NY
Click here to add this to my saved trials
Orange, California 92868
2578
mi
from 02139
Orange, CA
Click here to add this to my saved trials
801 North Flamingo Road
Pembroke Pines, Florida 33028
1244
mi
from 02139
Pembroke Pines, FL
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
477
mi
from 02139
Pittsburgh, PA
Click here to add this to my saved trials
1201 5th Avenue North
Saint Petersburg, Florida 33719
1198
mi
from 02139
Saint Petersburg, FL
Click here to add this to my saved trials
2100 Webster Street
San Francisco, California 94115
2690
mi
from 02139
San Francisco, CA
Click here to add this to my saved trials
2274
mi
from 02139
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85745
2279
mi
from 02139
Tucson, AZ
Click here to add this to my saved trials
393
mi
from 02139
Washington,
Click here to add this to my saved trials
York, Pennsylvania 17403
335
mi
from 02139
York, PA
Click here to add this to my saved trials