Clinical Trials List
2016-09-01 - 2020-11-09
Phase II
Terminated8
ICD-10C50
Malignant neoplasm of breast
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.
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Trial Applicant
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Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Yi-Fang Tsai Division of General Surgery
- Chun-Yu Liu Division of Hematology & Oncology
- 邱仁輝 Division of General Surgery
- 林永慧 Division of Radiology
- 金光亮 Division of General Surgery
- Ta-Chung Chao Division of Hematology & Oncology
- 林燕淑 Division of General Surgery
The Actual Total Number of Participants Enrolled
1 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yao-Chung Wu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
- Liang-Chih Liu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Fang-Ming Chen Division of General Surgery
- Fu Ouyang Division of General Surgery
- 甘蓉瑜 Division of General Surgery
- Chieh-Han Chuang Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Yung-Chang Lin Division of Hematology & Oncology
- Wen-Chi Shen Division of Hematology & Oncology
- Mengting Peng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- SUNG-HSIN KUO Division of Radiation Therapy
- Wei-Wu Chen Division of Hematology & Oncology
- 郭文宏 Division of General Surgery
- 蔡立威 Division of General Surgery
- 林柏翰 Division of General Internal Medicine
- 羅喬 Division of General Surgery
- 張端瑩 Division of Hematology & Oncology
- MING-YANG WANG Division of General Surgery
- YEN-SHEN LU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary efficacy objective for this study is to evaluate the efficacy of the combination
of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine
plus placebo on the basis of the following endpoint:
• PFS, defined as the time from randomization to the first occurrence of disease
progression, as determined by investigator assessment using RECIST v1.1, or
death from any cause, whichever occurs first
Secondary Efficacy Objectives
The secondary efficacy objectives for this study are to evaluate the efficacy of the
combination of trastuzumab emtansine plus atezolizumab compared with trastuzumab
emtansine plus placebo on the basis of the following endpoints:
• OS, defined as the time from randomization to death from any cause
• Objective response, defined as a CR or PR on two consecutive assessments, at
least 28 days apart, as determined by investigator assessment using RECIST v1.1
• Duration of objective response, defined as the time from first occurrence of a
documented objective response to disease progression, as determined by
investigator assessment using RECIST v1.1 or death from any cause, whichever
occurs first
Exploratory Efficacy Objectives
The exploratory efficacy objectives for this study are to evaluate the efficacy of the
combination of trastuzumab emtansine plus atezolizumab compared with trastuzumab
emtansine plus placebo on the basis of the following endpoints:
• PFS, defined as the time from randomization to the first occurrence of disease
progression, as determined by investigator assessment using RECIST v1.1 or death
from any cause, whichever occurs first, in the PD-L1 selected subgroup of patients
defined as having tumor immune infiltrating cell expression of IC 1/2/3, as assessed
by immunohistochemistry (IHC)
• PFS, defined as the time from randomization to the first occurrence of disease
progression, as determined by investigator assessment using immune-modified
RECIST or death from any cause, whichever occurs first
• Objective response, defined as a CR or PR on two consecutive assessments, at
least 28 days apart, as determined by investigator assessment using
immune-modified RECIST
• Duration of objective response, defined as the time from first occurrence of a
documented objective response to disease progression, as determined by
investigator assessment using immune-modified RECIST or death from any cause,
whichever occurs first
• 1-year survival rate
Inclution 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
The Estimated Number of Participants
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Taiwan
24 participants
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Global
200 participants
