TriangleNCT03498716 · OUTCOME
Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
What was measured
iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
Analysis population: PD-L1-positive subpopulation included participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received.
Groups in this outcome
Chemotherapy
Participants were administered paclitaxel, 80 mg/m\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.
Atezolizumab and Chemotherapy
Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
| Group | Source count |
|---|---|
| Chemotherapy | 782 |
| Atezolizumab and Chemotherapy | 785 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy | NA | Not reported | NA | NA | Median and 95% CI for iDFS were not estimable due to too few events having occurred. |
| Atezolizumab and Chemotherapy | NA | Not reported | NA | NA | Median and 95% CI for iDFS were not estimable due to too few events having occurred. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and 95% CI for iDFS were not estimable due to too few events having occurred.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% CI for iDFS were not estimable due to too few events having occurred.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 782
- group Id
- OG001
- value
- 785
- units
- Participants
- description
- iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered paclitaxel, 80 mg/m\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.
- id
- OG000
- title
- Chemotherapy
- description
- Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
- id
- OG001
- title
- Atezolizumab and Chemotherapy
- param Type
- MEDIAN
- population Description
- PD-L1-positive subpopulation included participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received.
- reporting Status
- POSTED
- time Frame
- From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
- title
- Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice