TriangleNCT05654623 · OUTCOME
Duration of Response (DOR) by BICR Assessment
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 first documentation of objective tumor response until confirmed PD or death, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
What was measured
DOR was defined as time from first documentation of objective tumor response (CR or PR) to first documentation of PD, or death due to any cause, whichever occurred first. CR: complete disappearance of all target lesions, of all non-target lesions and no new lesions; except for nodal disease, all nodes decreased to normal (short axis \<10 mm); all disease sites, all target lesions assessed. PR: \>=30% decrease from baseline in sum of diameters of all target lesions, non-PD/not evaluated for non-target lesions and no new lesions; all target lesions were assessed. The short diameter is used in the sum for nodal target lesions, while longest diameter is used in sum for non-nodal target lesions, all target lesions were assessed. DOR was analyzed in participants with an OR. PD: at least 20% increase in sum of diameters of target measurable lesions above nadir, with minimum absolute increase of 5 mm relative to nadir or unequivocal progression of existing non-target lesions, or new lesions.
Analysis population: FAS included all enrolled participants who were randomized. Here, "Overall Number of Participants Analyzed" included the participants evaluable for this outcome measure.
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 | 24 |
| Fulvestrant | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vepdegestrant | NA | Not reported | 5.6 | NA | Median and upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Fulvestrant | 7.4 | Not reported | 5.6 | NA | Upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 7.4
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- DOR was defined as time from first documentation of objective tumor response (CR or PR) to first documentation of PD, or death due to any cause, whichever occurred first. CR: complete disappearance of all target lesions, of all non-target lesions and no new lesions; except for nodal disease, all nodes decreased to normal (short axis \<10 mm); all disease sites, all target lesions assessed. PR: \>=30% decrease from baseline in sum of diameters of all target lesions, non-PD/not evaluated for non-target lesions and no new lesions; all target lesions were assessed. The short diameter is used in the sum for nodal target lesions, while longest diameter is used in sum for non-nodal target lesions, all target lesions were assessed. DOR was analyzed in participants with an OR. PD: at least 20% increase in sum of diameters of target measurable lesions above nadir, with minimum absolute increase of 5 mm relative to nadir or unequivocal progression of existing non-target lesions, or new lesions.
- 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
- MEDIAN
- population Description
- FAS included all enrolled participants who were randomized. Here, "Overall Number of Participants Analyzed" included the participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first documentation of objective tumor response until confirmed PD or death, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
- title
- Duration of Response (DOR) by BICR Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice