Trial · NCT03197935
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | 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. |
| Primary | Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | 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. |
| Secondary | Event-Free Survival (EFS) in All Participants | 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. |
| Secondary | Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | 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. |
| Secondary | Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | 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. |
| Secondary | Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery | 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. |
| Secondary | Overall Survival (OS) in All Participants | 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. |
| Secondary | Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status | 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. |
| Secondary | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | 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). |
| Secondary | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | 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). |
| Secondary | Percentage of Participants With at Least One Adverse Events (AEs) | From randomization and up to study final analysis data cut off on 28 September 2022. | Percentage of participants with at least one adverse event. |
| Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | 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. |
| Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Day 1 of Cycle 1 post dose (cycle length = 28 days) | Maximum observed atezolizumab concentration (Cmax). |
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Baseline up to approximately 20 months | Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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