TriangleNCT05654623 · OUTCOME
Percentage of Participants With Objective Response (OR) by BICR Assessment- Participants With Measurable Disease at Baseline
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
- 95% Confidence Interval
- Time frame
- From randomization until PD, death or start of new anticancer therapy, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
What was measured
OR was defined as the best overall response of confirmed complete response (CR) or partial response (PR) by BICR assessment as per RECIST v1.1 criteria. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions, with the exception of nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes decreased to normal (short axis \<10 mm); all target lesions and disease sites were assessed. PR was defined as at least a 30% decrease from baseline in the sum of diameters of all target lesions, non-PD/not evaluated for the non-target lesions and no new lesions. The short diameter was used in the sum for nodal target lesions, while the longest diameter was used in the sum for non-nodal target lesions, all target lesions were assessed.
Analysis population: FAS included all enrolled participants who were randomized. Here, "Overall Number of Participants Analyzed" included the participants with measurable disease at baseline (last available assessments collected on or prior to randomization date).
Groups in this outcome
Vepdegestrant
Participants were randomized to receive vepdegestrant 200 mg orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
Fulvestrant
Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
| Group | Source count |
|---|---|
| Vepdegestrant | 221 |
| Fulvestrant | 222 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vepdegestrant | 10.9 | Not reported | 7.4 | 15.6 | Not reported |
| Fulvestrant | 3.6 | Not reported | 1.8 | 6.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.4
- upper Limit
- 15.6
- value
- 10.9
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 6.9
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 221
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- OR was defined as the best overall response of confirmed complete response (CR) or partial response (PR) by BICR assessment as per RECIST v1.1 criteria. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions, with the exception of nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes decreased to normal (short axis \<10 mm); all target lesions and disease sites were assessed. PR was defined as at least a 30% decrease from baseline in the sum of diameters of all target lesions, non-PD/not evaluated for the non-target lesions and no new lesions. The short diameter was used in the sum for nodal target lesions, while the longest diameter was used in the sum for non-nodal target lesions, all target lesions were assessed.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive vepdegestrant 200 mg orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
- id
- OG000
- title
- Vepdegestrant
- description
- Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
- id
- OG001
- title
- Fulvestrant
- param Type
- NUMBER
- population Description
- FAS included all enrolled participants who were randomized. Here, "Overall Number of Participants Analyzed" included the participants with measurable disease at baseline (last available assessments collected on or prior to randomization date).
- reporting Status
- POSTED
- time Frame
- From randomization until PD, death or start of new anticancer therapy, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
- title
- Percentage of Participants With Objective Response (OR) by BICR Assessment- Participants With Measurable Disease at Baseline
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice