TriangleNCT00542451 · OUTCOME
Disease Free Survival (DFS) in Patients With Tumors Measuring ≤1 cm or > 1 cm
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
- at 3 years
What was measured
DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
Groups in this outcome
[Primary Tumor ≤ 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer
80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
[Primary Tumor > 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer
80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
| Group | Source count |
|---|---|
| [Primary Tumor ≤ 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer | 201 |
| [Primary Tumor > 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer | 205 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| [Primary Tumor ≤ 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer | NA | Not reported | NA | NA | The lower limit of the 95% confidence interval for the Kaplan Meier curves did not cross 50%. Therefore we cannot get a lower bound of the 95% confidence interval for the median. There are insufficient numbers of participants with events and hence median survival was not reached and the 95% confidence intervals could not be estimated either. |
| [Primary Tumor > 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer | NA | Not reported | NA | NA | The lower limit of the 95% confidence interval for the Kaplan Meier curves did not cross 50%. Therefore we cannot get a lower bound of the 95% confidence interval for the median. There are insufficient numbers of participants with events and hence median survival was not reached and the 95% confidence intervals could not be estimated either. |
Complete source fields
- classes
- categories
- measurements
- comment
- The lower limit of the 95% confidence interval for the Kaplan Meier curves did not cross 50%. Therefore we cannot get a lower bound of the 95% confidence interval for the median. There are insufficient numbers of participants with events and hence median survival was not reached and the 95% confidence intervals could not be estimated either.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The lower limit of the 95% confidence interval for the Kaplan Meier curves did not cross 50%. Therefore we cannot get a lower bound of the 95% confidence interval for the median. There are insufficient numbers of participants with events and hence median survival was not reached and the 95% confidence intervals could not be estimated either.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 205
- units
- Participants
- description
- DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
- id
- OG000
- title
- [Primary Tumor ≤ 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- description
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
- id
- OG001
- title
- [Primary Tumor > 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- at 3 years
- title
- Disease Free Survival (DFS) in Patients With Tumors Measuring ≤1 cm or > 1 cm
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice