TriangleNCT00976989 · OUTCOME
Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
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
- At surgery, after 18 weeks (6 cycles) of treatment
What was measured
pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.
Analysis population: Intent to treat (ITT) population included all participants who were randomized to treatment.
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 | 73 |
| T+P Sequential Anthracycline-based Chemotherapy | 75 |
| T+P Concomitant Non-Anthracycline Chemotherapy | 77 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | 61.6 | Not reported | 49.5 | 72.8 | Not reported |
| T+P Sequential Anthracycline-based Chemotherapy | 57.3 | Not reported | 45.4 | 68.7 | Not reported |
| T+P Concomitant Non-Anthracycline Chemotherapy | 66.2 | Not reported | 54.6 | 76.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.5
- upper Limit
- 72.8
- value
- 61.6
- group Id
- OG001
- lower Limit
- 45.4
- upper Limit
- 68.7
- value
- 57.3
- group Id
- OG002
- lower Limit
- 54.6
- upper Limit
- 76.6
- value
- 66.2
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 77
- units
- Participants
- description
- pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.
- dispersion Type
- 95% Confidence Interval
- 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
- Intent to treat (ITT) population included all participants who were randomized to treatment.
- reporting Status
- POSTED
- time Frame
- At surgery, after 18 weeks (6 cycles) of treatment
- title
- Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice