TriangleNCT05654623 · OUTCOME
Clinical Benefit Rate (CBR) by BICR Assessment
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 due to any cause 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
CBR: percentage of participants with clinical benefit response. Clinical benefit response: confirmed CR or PR at any time, or stable disease (SD) \>=24 weeks per RECIST v1.1. 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 assessed. SD: did not qualify for CR, PR, PD. All target lesions assessed. PD per RECIST v1.1: at least 20% increased sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to timepoint under evaluation), with minimum absolute increase of 5mm 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" signifies number of 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 | 274 |
| Fulvestrant | 272 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vepdegestrant | 34.3 | Not reported | 28.9 | 40.1 | Not reported |
| Fulvestrant | 28.7 | Not reported | 23.6 | 34.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.9
- upper Limit
- 40.1
- value
- 34.3
- group Id
- OG001
- lower Limit
- 23.6
- upper Limit
- 34.3
- value
- 28.7
- denoms
- counts
- group Id
- OG000
- value
- 274
- group Id
- OG001
- value
- 272
- units
- Participants
- description
- CBR: percentage of participants with clinical benefit response. Clinical benefit response: confirmed CR or PR at any time, or stable disease (SD) \>=24 weeks per RECIST v1.1. 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 assessed. SD: did not qualify for CR, PR, PD. All target lesions assessed. PD per RECIST v1.1: at least 20% increased sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to timepoint under evaluation), with minimum absolute increase of 5mm 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
- NUMBER
- population Description
- FAS included all enrolled participants who were randomized. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From randomization until PD, death due to any cause 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
- Clinical Benefit Rate (CBR) by BICR Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice