TriangleNCT03901339 · OUTCOME
PFS by LIR 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
- Up to 42.8 months
What was measured
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. 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. PFS was estimated using Kaplan-Meier estimate.
Analysis population: Participants in the ITT 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 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 4.3 | Not reported | 3.8 | 5.4 | Not reported |
| Treatment of Physician's Choice (TPC) | 3.1 | Not reported | 2.7 | 4.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.602
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.881
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0010
- p Value Comment
- Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.728
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.602
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.881
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0010
- p Value Comment
- Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.728
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.8
- upper Limit
- 5.4
- value
- 4.3
- group Id
- OG001
- lower Limit
- 2.7
- upper Limit
- 4.0
- value
- 3.1
- denoms
- counts
- group Id
- OG000
- value
- 272
- group Id
- OG001
- value
- 271
- units
- Participants
- description
- PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. 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. PFS was estimated using Kaplan-Meier estimate.
- 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
- MEDIAN
- population Description
- Participants in the ITT Population were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 42.8 months
- title
- PFS by LIR Assessment
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice