TriangleNCT02574455 · OUTCOME
Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
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 to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
What was measured
CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. 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; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Analysis population: Participants in the BM-ve Population were analyzed.
Groups in this outcome
Sacituzumab Govitecan
Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Treatment of Physician's Choice (TPC)
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively). 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 for up to 10.6 months. Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
| Group | Source count |
|---|---|
| Sacituzumab Govitecan | 235 |
| Treatment of Physician's Choice (TPC) | 233 |
Reported measurements
IRC Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 44.7 | Not reported | 38.2 | 51.3 | Not reported |
| Treatment of Physician's Choice (TPC) | 8.6 | Not reported | 5.3 | 12.9 | Not reported |
Investigator Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 45.5 | Not reported | 39.0 | 52.1 | Not reported |
| Treatment of Physician's Choice (TPC) | 10.3 | Not reported | 6.7 | 14.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 5.055
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.437
- group Description
- CBR by IRC Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 8.543
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 4.540
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.364
- group Description
- CBR by Investigator Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 7.492
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 5.055
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.437
- group Description
- CBR by IRC Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 8.543
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 4.540
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.364
- group Description
- CBR by Investigator Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 7.492
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.2
- upper Limit
- 51.3
- value
- 44.7
- group Id
- OG001
- lower Limit
- 5.3
- upper Limit
- 12.9
- value
- 8.6
- title
- IRC Assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.0
- upper Limit
- 52.1
- value
- 45.5
- group Id
- OG001
- lower Limit
- 6.7
- upper Limit
- 14.9
- value
- 10.3
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 235
- group Id
- OG001
- value
- 233
- units
- Participants
- description
- CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. 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; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing 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 either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
- id
- OG000
- title
- Sacituzumab Govitecan
- description
- Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively). 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 for up to 10.6 months. Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 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 BM-ve Population were analyzed.
- reporting Status
- POSTED
- time Frame
- From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
- title
- Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice