Clinical Trials List
Protocol NumberBO40747
Completed
2018-12-01 - 2024-12-31
Phase III
Terminated4
ICD-10C50
Malignant neoplasm of breast
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH NEOADJUVANT DOXORUBICIN + CYCLOPHOSPHAMIDE FOLLOWED BY PACLITAXEL + TRASTUZUMAB + PERTUZUMAB IN EARLY HER2-POSITIVE BREAST CANCER
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Trial Applicant
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Linkou Chang Gung Medical Foundation
Taiwan National PI
陳訓徹
Co-Principal Investigator
- 周旭桓 Division of General Surgery
- Wen-Ling Kuo Division of General Surgery
- Yung-Chang Lin Division of Hematology & Oncology
- Chi-Chang Yu Division of General Surgery
- Wen-Chi Shen Division of Hematology & Oncology
- 沈士哲 Division of General Surgery
- 翁世樺 Division of Others
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- Chen-Teng Wu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
- 林智一 Division of Others
- Liang-Chih Liu Division of General Surgery
- 張慧雯 Division of Others
- Yao-Chung Wu Division of General Surgery
The Actual Total Number of Participants Enrolled
12 Terminated
Condition/Disease
EARLY HER2-POSITIVE BREAST CANCER
Objectives
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin cyclophosphamide) followed by paclitaxel trastuzumab pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer at high risk of recurrence (T2-4, N1-3, M0).
Test Drug
Atezolizumab
Active Ingredient
Dosage Form
Dosage
1200mg/20mL
420mg/14ml
150 mg
420mg/14ml
150 mg
Endpoints
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin cyclophosphamide) followed by paclitaxel trastuzumab pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer at high risk of recurrence (T2-4, N1-3, M0).
Inclution Criteria
Signed Informed Consent Form
Age 18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, in the investigator's judgment
Confirmed diagnosis of HER2-positive breast cancer, and hormonal and PD-L1 status, as
documented through central testing of a representative tumor tissue specimen, is required.
HER2-positive status will be determined based on pretreatment breast biopsy material
and defined as an IHC score of 3 or positive by in situ hybridization (ISH) prospectively assessed by a central laboratory prior to study enrollment. ISH positivity is defined as a ratio of 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies. A central laboratory will perform both IHC and ISH assays; however, only one positive result is required for eligibility.
PD-L1 status through measurement of IHC will be used for stratification. A formalinfixed
paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 20 slides containing unstained, freshly cut, serial sections must be submitted prior to study enrollment. Any deviation of the material requirements are only allowed after Sponsor’s approval has been obtained.
ER/PgR status will be determined centrally based on pretreatment breast biopsy material according to the American Society of Clinical Oncology (ASCO) and the College of American Pathologists guidelines (Hammond et al. 2010).
Age 18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, in the investigator's judgment
Confirmed diagnosis of HER2-positive breast cancer, and hormonal and PD-L1 status, as
documented through central testing of a representative tumor tissue specimen, is required.
HER2-positive status will be determined based on pretreatment breast biopsy material
and defined as an IHC score of 3 or positive by in situ hybridization (ISH) prospectively assessed by a central laboratory prior to study enrollment. ISH positivity is defined as a ratio of 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies. A central laboratory will perform both IHC and ISH assays; however, only one positive result is required for eligibility.
PD-L1 status through measurement of IHC will be used for stratification. A formalinfixed
paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 20 slides containing unstained, freshly cut, serial sections must be submitted prior to study enrollment. Any deviation of the material requirements are only allowed after Sponsor’s approval has been obtained.
ER/PgR status will be determined centrally based on pretreatment breast biopsy material according to the American Society of Clinical Oncology (ASCO) and the College of American Pathologists guidelines (Hammond et al. 2010).
Exclusion Criteria
Prior history of invasive breast cancer
Stage IV (metastatic) breast cancer
Baseline tumor staging procedures should be performed in alignment with AJCC
staging system, 8th edition (specifically in accordance with Anatomic Stage group
rules).
Prior systemic therapy for treatment of breast cancer
Previous therapy with anthracyclines or taxanes for any malignancy
Ulcerating breast cancer
Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of
neoadjuvant therapy
History of other malignancy within 5 years prior to screening, with the exception of those who patients have a negligible risk of metastasis or death (e.g., 5-year OS of 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Cardiopulmonary dysfunction as defined by any of the following prior to andomization:
- History of congestive heart failure of any classification
- Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not
controlled by adequate medication, severe conduction abnormality, or clinically
significant valvular disease
- High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate 100/min at
rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade
atrioventricular [AV]-block [second-degree AV-block Type 2 [Mobitz 2] or third degree
AV-block])
- Significant symptoms (Grade 2) relating to left ventricular dysfunction, cardiac
arrhythmia, or cardiac ischemia
- Myocardial infarction within 12 months prior to randomization
- Uncontrolled hypertension (systolic blood pressure 180 mmHg and/or diastolic blood
pressure 100 mmHg)
- Evidence of transmural infarction on ECG
- Requirement for oxygen therapy
Dyspnea at rest
Stage IV (metastatic) breast cancer
Baseline tumor staging procedures should be performed in alignment with AJCC
staging system, 8th edition (specifically in accordance with Anatomic Stage group
rules).
Prior systemic therapy for treatment of breast cancer
Previous therapy with anthracyclines or taxanes for any malignancy
Ulcerating breast cancer
Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of
neoadjuvant therapy
History of other malignancy within 5 years prior to screening, with the exception of those who patients have a negligible risk of metastasis or death (e.g., 5-year OS of 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Cardiopulmonary dysfunction as defined by any of the following prior to andomization:
- History of congestive heart failure of any classification
- Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not
controlled by adequate medication, severe conduction abnormality, or clinically
significant valvular disease
- High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate 100/min at
rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade
atrioventricular [AV]-block [second-degree AV-block Type 2 [Mobitz 2] or third degree
AV-block])
- Significant symptoms (Grade 2) relating to left ventricular dysfunction, cardiac
arrhythmia, or cardiac ischemia
- Myocardial infarction within 12 months prior to randomization
- Uncontrolled hypertension (systolic blood pressure 180 mmHg and/or diastolic blood
pressure 100 mmHg)
- Evidence of transmural infarction on ECG
- Requirement for oxygen therapy
Dyspnea at rest
The Estimated Number of Participants
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Taiwan
50 participants
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Global
224 participants
