TriangleNCT01945775 · OUTCOME
Time to Deterioration (TTD) in Breast Symptoms Scale as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)
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
- Baseline up to a maximum duration of 36.9 months
What was measured
TTD was defined as the time (in months) from randomization to the first observation with a\>=10 point increase and no subsequent observations with a \<10 point increase from baseline in breast symptom score based on the EORTC-QLQ-BR23. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.
Analysis population: PRO-evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post-baseline.
Groups in this outcome
Talazoparib
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Physician's Choice Treatment
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
| Group | Source count |
|---|---|
| Talazoparib | 262 |
| Physician's Choice Treatment | 114 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Talazoparib | NA | Not reported | NA | NA | Median and 95% CI was not estimable due to the low number of participants with event. |
| Physician's Choice Treatment | NA | Not reported | 10.3 | NA | Median and upper limit of 95% CI was not estimable due to the low number of participants with event. |
Source statistical analyses
- ci Lower Limit
- 0.198
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.775
- group Description
- Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0053
- param Type
- Hazard Ratio (HR)
- param Value
- 0.392
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.198
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.775
- group Description
- Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0053
- param Type
- Hazard Ratio (HR)
- param Value
- 0.392
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median and 95% CI was not estimable due to the low number of participants with event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and upper limit of 95% CI was not estimable due to the low number of participants with event.
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 262
- group Id
- OG001
- value
- 114
- units
- Participants
- description
- TTD was defined as the time (in months) from randomization to the first observation with a\>=10 point increase and no subsequent observations with a \<10 point increase from baseline in breast symptom score based on the EORTC-QLQ-BR23. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
- id
- OG000
- title
- Talazoparib
- description
- Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
- id
- OG001
- title
- Physician's Choice Treatment
- param Type
- MEDIAN
- population Description
- PRO-evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post-baseline.
- reporting Status
- POSTED
- time Frame
- Baseline up to a maximum duration of 36.9 months
- title
- Time to Deterioration (TTD) in Breast Symptoms Scale as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- months
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Preserved source evidence · Not medical advice