TriangleNCT03901339 · OUTCOME
Clinical Benefit Rate (CBR) by BICR and LIR 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
- Up to 42.8 months
What was measured
CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions.
Analysis population: Participants in the ITT Population with available data were analyzed.
Groups in this outcome
Sacituzumab Govitecan
Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
Treatment of Physician's Choice (TPC)
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
| Group | Source count |
|---|---|
| Sacituzumab Govitecan | 272 |
| Treatment of Physician's Choice (TPC) | 271 |
Reported measurements
CBR by BICR Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 33.8 | Not reported | 28.2 | 39.8 | Not reported |
| Treatment of Physician's Choice (TPC) | 22.1 | Not reported | 17.3 | 27.6 | Not reported |
CBR by LIR Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 32.4 | Not reported | 26.8 | 38.3 | Not reported |
| Treatment of Physician's Choice (TPC) | 21.0 | Not reported | 16.3 | 26.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.227
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.628
- group Description
- CBR by BICR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0025
- param Type
- Odds Ratio (OR)
- param Value
- 1.796
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 1.237
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.717
- group Description
- CBR by LIR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0024
- param Type
- Odds Ratio (OR)
- param Value
- 1.834
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.227
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.628
- group Description
- CBR by BICR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0025
- param Type
- Odds Ratio (OR)
- param Value
- 1.796
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 1.237
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.717
- group Description
- CBR by LIR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0024
- param Type
- Odds Ratio (OR)
- param Value
- 1.834
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.2
- upper Limit
- 39.8
- value
- 33.8
- group Id
- OG001
- lower Limit
- 17.3
- upper Limit
- 27.6
- value
- 22.1
- title
- CBR by BICR Assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.8
- upper Limit
- 38.3
- value
- 32.4
- group Id
- OG001
- lower Limit
- 16.3
- upper Limit
- 26.4
- value
- 21.0
- title
- CBR by LIR Assessment
- denoms
- counts
- group Id
- OG000
- value
- 272
- group Id
- OG001
- value
- 271
- units
- Participants
- description
- CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
- id
- OG000
- title
- Sacituzumab Govitecan
- description
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
- id
- OG001
- title
- Treatment of Physician's Choice (TPC)
- param Type
- NUMBER
- population Description
- Participants in the ITT Population with available data were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 42.8 months
- title
- Clinical Benefit Rate (CBR) by BICR and LIR Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice