TriangleNCT02101788 · OUTCOME
Progression-free Survival (PFS)
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 progression or death, an average of 7 months for arm A and 13 months for arm B
What was measured
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.
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 | 7.2 | Not reported | 5.6 | 9.9 | Not reported |
| Arm B - Experimental Arm | 13.0 | Not reported | 9.9 | 15.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 9.9
- value
- 7.2
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 15.0
- value
- 13.0
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 130
- units
- Participants
- description
- Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.
- 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 progression or death, an average of 7 months for arm A and 13 months for arm B
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice