TriangleNCT03498716 · OUTCOME
Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation
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 (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: Node positive subpopulation included all participants in the ITT population whose lymph node (LN) status was positive 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 | 533 |
| Atezolizumab and Chemotherapy | 534 |
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
- 533
- group Id
- OG001
- value
- 534
- 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 (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
- Node positive subpopulation included all participants in the ITT population whose lymph node (LN) status was positive 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 Node Positive Subpopulation
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice