Cancer
Conditions
Interventions
placebo plus trastuzumab emtansine
Atezolizumab plus trastuzumab emtansine
Sponsors
Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed invasive breast carcinoma -Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer -Centrally confirmed PD-L1 and hormone receptor status -Clinical stage at disease presentation: cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible) -Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted) = 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55% -Life expectancy >= 6 months -Adequate hematologic and end organ function
Exclusion criteria
Exclusion criteria: -Stage IV breast cancer -An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy -Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors -History of exposure to various cumulative doses of anthracyclines -History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS) -Current grade >=2 peripheral neuropathy -History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis -History of or active autoimmune disease or immune deficiency -Treatment with immunostimulatory or immunosuppressive agents -Cardiopulmonary dysfunction -Any known active liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive Disease-free Survival (IDFS) IDFS event is defined as the time from randomization to the first occurrence of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| IDFS Including Second Primary Non-breast Invasive Cancer [ Time Frame: From baseline up to 10 years ] Disease-free Survival (DFS) [ Time Frame: From baseline up to 10 years ] Overall Survival (OS) [ Time Frame: From baseline up to 10 years ] Distant Recurrence-free Interval (DRFI) [ Time Frame: From baseline up to 10 years ] Number of Participants with Clinically Meaningful Deterioration in Global Health Status/Quality of Life (GHS/QoL) Physical, Role, and Cognitive Function [ Time Frame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years) ] Clinically Meaningful Deterioration will be Measured by Scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ C30) Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30 [ Time Frame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years) ] The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms. ;Mean Change From Baseline Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30 [ Time Frame: From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years) ] The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at | — |
Countries
Kenya, Uganda
Contacts
Public ContactEileen Koske
Country Study and SSU Manager East Africa
Outcome results
None listed