TriangleNCT02445391 · OUTCOME
3-year Recurrence-Free Survival (RFS) 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
RFS was defined as time from randomization to local/regional recurrence, distant recurrence or death, whichever occurred first. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of RFS events. 3-year RFS 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) | 46.2 | Not reported | 34.7 | 57.0 | Not reported |
| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 49.3 | Not reported | 38.9 | 58.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.7
- upper Limit
- 57.0
- value
- 46.2
- group Id
- OG001
- lower Limit
- 38.9
- upper Limit
- 58.9
- value
- 49.3
- denoms
- counts
- group Id
- OG000
- value
- 148
- group Id
- OG001
- value
- 160
- units
- Participants
- description
- RFS was defined as time from randomization to local/regional recurrence, distant recurrence or death, whichever occurred first. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of RFS events. 3-year RFS 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 Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice