Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
DrugAtezolizumab was administered as per schedule described in respective arm.
NCT Number: NCT03197935
This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Monash Medical Centre, Clayton, Victoria, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atezolizumab was administered as per schedule described in respective arm.
Placebo matched to atezolizumab was administered as per schedule described in respective arm.
Nab-paclitaxel was administered as per schedule described in the arms.
Doxorubicin was administered as per schedule described in the arms.
Cyclophosphamide was administered as per schedule described in the arms.
Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Time frame: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time frame: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell [IC] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time frame: From surgery and up to study final analysis data cut off on 28 September 2022.
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.
Time frame: From surgery and up to study final analysis data cut off on 28 September 2022.
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Percentage of participants with at least one adverse event.
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)
Minimum observed serum atezolizumab concentration.
Time frame: Day 1 of Cycle 1 post dose (cycle length = 28 days)
Maximum observed atezolizumab concentration (Cmax).
Time frame: Baseline up to approximately 20 months
Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.
Hoffmann-La Roche
Industry
A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
Acronym: IMpassion031
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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