TriangleNCT05169567 · OUTCOME
Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
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
- Not reported
- Time frame
- Randomization until measured progressive disease (Up to 22 Months)
What was measured
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Analysis population: All randomized participants.
Groups in this outcome
Arm A: Abemaciclib Plus Fulvestrant
Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
Arm B: Placebo Plus Fulvestrant
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
| Group | Source count |
|---|---|
| Arm A: Abemaciclib Plus Fulvestrant | 182 |
| Arm B: Placebo Plus Fulvestrant | 186 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Abemaciclib Plus Fulvestrant | 24 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Placebo Plus Fulvestrant | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 186
- units
- Participants
- description
- ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
- groups
- description
- Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- OG000
- title
- Arm A: Abemaciclib Plus Fulvestrant
- description
- Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- OG001
- title
- Arm B: Placebo Plus Fulvestrant
- param Type
- NUMBER
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Randomization until measured progressive disease (Up to 22 Months)
- title
- Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice