TriangleNCT02101788 · OUTCOME
Overall Survival
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
- Time from study entry to time of death or date of last contact, an average of 29 months for arm A and 37 months for arm B
What was measured
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.
Analysis population: All randomized patients
Groups in this outcome
Arm A - Control Arm
Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
Arm B - Experimental Arm
Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
| Group | Source count |
|---|---|
| Arm A - Control Arm | 130 |
| Arm B - Experimental Arm | 130 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Control Arm | 29.2 | Not reported | 23.5 | 51.6 | Not reported |
| Arm B - Experimental Arm | 37.0 | Not reported | 30.3 | Not reported | insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.5
- upper Limit
- 51.6
- value
- 29.2
- comment
- insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 30.3
- value
- 37.0
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 130
- units
- Participants
- description
- Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
- id
- OG000
- title
- Arm A - Control Arm
- description
- Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
- id
- OG001
- title
- Arm B - Experimental Arm
- param Type
- MEDIAN
- population Description
- All randomized patients
- reporting Status
- POSTED
- time Frame
- Time from study entry to time of death or date of last contact, an average of 29 months for arm A and 37 months for arm B
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice