NCT01566721 · OUTCOME
Disease-Free Survival Rate
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer · Source last updated 2021-04-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Kaplan-Meier survival probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Baseline to time of event (up to approximately 8 years)
What was measured
DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.
Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
Analysis population: ITT Population who completed Safety Follow-up
Groups in this outcome
Cohort A: SC Herceptin by Needle/Syringe
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 1865 |
|---|
| Cohort B: SC Herceptin by SID | 708 |
|---|
Reported measurements
0.5 Year
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.990 | Not reported | 0.984 | 0.993 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.987 | Not reported | 0.976 | 0.993 | Not reported |
|---|
1 Year
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.975 | Not reported | 0.967 | 0.981 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.976 | Not reported | 0.961 | 0.985 | Not reported |
|---|
1.5 Year
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.960 | Not reported | 0.950 | 0.968 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.957 | Not reported | 0.939 | 0.970 | Not reported |
|---|
2 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.934 | Not reported | 0.921 | 0.944 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.939 | Not reported | 0.918 | 0.955 | Not reported |
|---|
3 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.904 | Not reported | 0.889 | 0.917 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.896 | Not reported | 0.870 | 0.916 | Not reported |
|---|
4 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.881 | Not reported | 0.865 | 0.896 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.874 | Not reported | 0.847 | 0.897 | Not reported |
|---|
5 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.868 | Not reported | 0.851 | 0.883 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.863 | Not reported | 0.835 | 0.887 | Not reported |
|---|
6 Years
Values in Kaplan-Meier survival probability · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A: SC Herceptin by Needle/Syringe | 0.851 | Not reported | 0.833 | 0.867 | Not reported |
|---|
| Cohort B: SC Herceptin by SID | 0.853 | Not reported | 0.824 | 0.878 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.984
- upper Limit
- 0.993
- value
- 0.990
- group Id
- OG001
- lower Limit
- 0.976
- upper Limit
- 0.993
- value
- 0.987
- title
- 0.5 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.967
- upper Limit
- 0.981
- value
- 0.975
- group Id
- OG001
- lower Limit
- 0.961
- upper Limit
- 0.985
- value
- 0.976
- title
- 1 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.950
- upper Limit
- 0.968
- value
- 0.960
- group Id
- OG001
- lower Limit
- 0.939
- upper Limit
- 0.970
- value
- 0.957
- title
- 1.5 Year
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.921
- upper Limit
- 0.944
- value
- 0.934
- group Id
- OG001
- lower Limit
- 0.918
- upper Limit
- 0.955
- value
- 0.939
- title
- 2 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.889
- upper Limit
- 0.917
- value
- 0.904
- group Id
- OG001
- lower Limit
- 0.870
- upper Limit
- 0.916
- value
- 0.896
- title
- 3 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.865
- upper Limit
- 0.896
- value
- 0.881
- group Id
- OG001
- lower Limit
- 0.847
- upper Limit
- 0.897
- value
- 0.874
- title
- 4 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.851
- upper Limit
- 0.883
- value
- 0.868
- group Id
- OG001
- lower Limit
- 0.835
- upper Limit
- 0.887
- value
- 0.863
- title
- 5 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.833
- upper Limit
- 0.867
- value
- 0.851
- group Id
- OG001
- lower Limit
- 0.824
- upper Limit
- 0.878
- value
- 0.853
- title
- 6 Years
- denoms
- counts
- group Id
- OG000
- value
- 1865
- group Id
- OG001
- value
- 708
- units
- Participants
- description
- DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.
Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
- id
- OG000
- title
- Cohort A: SC Herceptin by Needle/Syringe
- description
- Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
- id
- OG001
- title
- Cohort B: SC Herceptin by SID
- param Type
- NUMBER
- population Description
- ITT Population who completed Safety Follow-up
- reporting Status
- POSTED
- time Frame
- From Baseline to time of event (up to approximately 8 years)
- title
- Disease-Free Survival Rate
- type
- SECONDARY
- unit Of Measure
- Kaplan-Meier survival probability
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