TriangleNCT01853748 · OUTCOME
3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3 years
What was measured
Disease-free survival (DFS) is evaluated in patients treated with trastuzumab emtansine, which is defined per protocol: from the time of randomization until the to the occurrence of the first of the following events: * Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast. * Contralateral invasive breast cancer, * Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description. * Death from any cause
Groups in this outcome
Trastuzumab Emtansine (T-DM1) With Tumor Size < 1 cm
T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
Trastuzumab Emtansine (T-DM1) With Tumor Size >= 1 cm
T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
| Group | Source count |
|---|---|
| Trastuzumab Emtansine (T-DM1) With Tumor Size < 1 cm | 163 |
| Trastuzumab Emtansine (T-DM1) With Tumor Size >= 1 cm | 220 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine (T-DM1) With Tumor Size < 1 cm | 98.7 | Not reported | 96.9 | 100 | Not reported |
| Trastuzumab Emtansine (T-DM1) With Tumor Size >= 1 cm | 97.2 | Not reported | 95 | 99.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 96.9
- upper Limit
- 100
- value
- 98.7
- group Id
- OG001
- lower Limit
- 95
- upper Limit
- 99.4
- value
- 97.2
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 220
- units
- Participants
- description
- Disease-free survival (DFS) is evaluated in patients treated with trastuzumab emtansine, which is defined per protocol: from the time of randomization until the to the occurrence of the first of the following events: * Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast. * Contralateral invasive breast cancer, * Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description. * Death from any cause
- dispersion Type
- 95% Confidence Interval
- groups
- description
- T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
- id
- OG000
- title
- Trastuzumab Emtansine (T-DM1) With Tumor Size < 1 cm
- description
- T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
- id
- OG001
- title
- Trastuzumab Emtansine (T-DM1) With Tumor Size >= 1 cm
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- 3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice