TriangleNCT02445391 · OUTCOME
3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
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
- No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.
What was measured
IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method.
Analysis population: The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).
Groups in this outcome
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)
Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
| Group | Source count |
|---|---|
| Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 148 |
| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 160 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 42.0 | Not reported | 30.5 | 53.1 | Not reported |
| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 49.4 | Not reported | 39.0 | 59.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.81
- estimate Comment
- The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
Complete source fields
- analyses
- ci Lower Limit
- 0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.81
- estimate Comment
- The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.5
- upper Limit
- 53.1
- value
- 42.0
- group Id
- OG001
- lower Limit
- 39.0
- upper Limit
- 59.0
- value
- 49.4
- denoms
- counts
- group Id
- OG000
- value
- 148
- group Id
- OG001
- value
- 160
- units
- Participants
- description
- IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
- id
- OG000
- title
- Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)
- description
- Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
- id
- OG001
- title
- Arm C (Capecitabine) (Open to Accrual 6/22/2016)
- param Type
- NUMBER
- population Description
- The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).
- reporting Status
- POSTED
- time Frame
- No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.
- title
- 3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice