TriangleNCT04975308 · OUTCOME
Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B)
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
- From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
What was measured
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Analysis population: All participants who were randomly assigned to either arm A or arm B and had achieved CR or PR responses (including censored). Number of participants censored in "Arm A=17," "Arm B=7."
Groups in this outcome
Arm A: Imlunestrant
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
Arm B: Investigator's Choice of Endocrine Therapy
Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
| Group | Source count |
|---|---|
| Arm A: Imlunestrant | 34 |
| Arm B: Investigator's Choice of Endocrine Therapy | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Imlunestrant | 11.10 | Not reported | 7.43 | 23.92 | Not reported |
| Arm B: Investigator's Choice of Endocrine Therapy | 7.39 | Not reported | 5.59 | 15.67 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.43
- upper Limit
- 23.92
- value
- 11.10
- group Id
- OG001
- lower Limit
- 5.59
- upper Limit
- 15.67
- value
- 7.39
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 21
- units
- Participants
- description
- DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
- id
- OG000
- title
- Arm A: Imlunestrant
- description
- Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
- id
- OG001
- title
- Arm B: Investigator's Choice of Endocrine Therapy
- param Type
- MEDIAN
- population Description
- All participants who were randomly assigned to either arm A or arm B and had achieved CR or PR responses (including censored). Number of participants censored in "Arm A=17," "Arm B=7."
- reporting Status
- POSTED
- time Frame
- From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
- title
- Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice