TriangleNCT03901339 · OUTCOME
Objective Response Rate (ORR) by BICR and Local Investigator Review (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
ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. 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.
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
ORR by BICR Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 21.3 | Not reported | 16.6 | 26.7 | Not reported |
| Treatment of Physician's Choice (TPC) | 14.0 | Not reported | 10.1 | 18.7 | Not reported |
ORR by LIR Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 16.5 | Not reported | 12.3 | 21.5 | Not reported |
| Treatment of Physician's Choice (TPC) | 9.2 | Not reported | 6.1 | 13.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.058
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.609
- group Description
- ORR by BICR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0268
- param Type
- Odds Ratio (OR)
- param Value
- 1.662
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 1.174
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.369
- group Description
- ORR by LIR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0098
- param Type
- Odds Ratio (OR)
- param Value
- 1.989
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.058
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.609
- group Description
- ORR by BICR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0268
- param Type
- Odds Ratio (OR)
- param Value
- 1.662
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 1.174
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.369
- group Description
- ORR by LIR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0098
- param Type
- Odds Ratio (OR)
- param Value
- 1.989
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.6
- upper Limit
- 26.7
- value
- 21.3
- group Id
- OG001
- lower Limit
- 10.1
- upper Limit
- 18.7
- value
- 14.0
- title
- ORR by BICR Assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.3
- upper Limit
- 21.5
- value
- 16.5
- group Id
- OG001
- lower Limit
- 6.1
- upper Limit
- 13.3
- value
- 9.2
- title
- ORR by LIR Assessment
- denoms
- counts
- group Id
- OG000
- value
- 272
- group Id
- OG001
- value
- 271
- units
- Participants
- description
- ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. 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.
- 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
- Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice