TriangleNCT00976989 · OUTCOME
Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event
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
- Not reported
- Time frame
- From baseline to end of study up to 5 years
What was measured
The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.
Analysis population: ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.
Groups in this outcome
T+P Concomitant Anthracycline-based Chemotherapy
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
T+P Sequential Anthracycline-based Chemotherapy
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
T+P Concomitant Non-Anthracycline Chemotherapy
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
| Group | Source count |
|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 69 |
| T+P Sequential Anthracycline-based Chemotherapy | 67 |
| T+P Concomitant Non-Anthracycline Chemotherapy | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 85.5 | Not reported | Not reported | Not reported | Not reported |
| T+P Sequential Anthracycline-based Chemotherapy | 88.1 | Not reported | Not reported | Not reported | Not reported |
| T+P Concomitant Non-Anthracycline Chemotherapy | 84.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 85.5
- group Id
- OG001
- value
- 88.1
- group Id
- OG002
- value
- 84.7
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 67
- group Id
- OG002
- value
- 72
- units
- Participants
- description
- The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.
- groups
- description
- 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
- id
- OG000
- title
- T+P Concomitant Anthracycline-based Chemotherapy
- description
- FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
- id
- OG001
- title
- T+P Sequential Anthracycline-based Chemotherapy
- description
- Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
- id
- OG002
- title
- T+P Concomitant Non-Anthracycline Chemotherapy
- param Type
- NUMBER
- population Description
- ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.
- reporting Status
- POSTED
- time Frame
- From baseline to end of study up to 5 years
- title
- Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice