TriangleNCT01853748 · OUTCOME
3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3 years
What was measured
Disease-free survival (DFS) is evaluated and 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)
T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
Paclitaxel + Trastuzumab
paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
| Group | Source count |
|---|---|
| Trastuzumab Emtansine (T-DM1) | 383 |
| Paclitaxel + Trastuzumab | 114 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine (T-DM1) | 0.978 | Not reported | 0.963 | 0.993 | Not reported |
| Paclitaxel + Trastuzumab | 0.934 | Not reported | 0.889 | 0.988 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.963
- upper Limit
- 0.993
- value
- 0.978
- group Id
- OG001
- lower Limit
- 0.889
- upper Limit
- 0.988
- value
- 0.934
- denoms
- counts
- group Id
- OG000
- value
- 383
- group Id
- OG001
- value
- 114
- units
- Participants
- description
- Disease-free survival (DFS) is evaluated and 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)
- description
- paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
- id
- OG001
- title
- Paclitaxel + Trastuzumab
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- 3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice