TriangleNCT02132949 · OUTCOME
Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period
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
- From Baseline until disease progression or death due to any cause up to 24 weeks (during the neoadjuvant treatment period; assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks])
What was measured
The clinical response rate was defined as the percentage of participants in the ITT population who achieved a complete response (CR) or partial response (PR) prior to surgery, according to RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. Participants were classified as missing or unevaluable if no assessments were measured prior to surgery on the ipsilateral breast. The 95% CIs were calculated using the Clopper-Pearson method; they were only calculated for responses (not for missing or unevaluable data).
Analysis population: ITT population: included all participants who were enrolled regardless of whether they received any study treatment, grouped according to the arm to which a participant was enrolled.
Groups in this outcome
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
| Group | Source count |
|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 199 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 201 |
Reported measurements
Clinical Response Rate (CR+PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 67.3 | Not reported | 60.35 | 73.80 | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 60.2 | Not reported | 53.07 | 67.02 | Not reported |
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 39.7 | Not reported | 32.85 | 46.86 | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 23.9 | Not reported | 18.16 | 30.39 | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 27.6 | Not reported | 21.55 | 34.41 | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 36.3 | Not reported | 29.67 | 43.38 | Not reported |
Stable Disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 7.0 | Not reported | 3.90 | 11.52 | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 10.0 | Not reported | 6.18 | 14.95 | Not reported |
Progressive Disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 0.5 | Not reported | 0.01 | 2.77 | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 1.0 | Not reported | 0.12 | 3.55 | Not reported |
Missing or Unevaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 25.1 | Not reported | NA | NA | 95% CIs were only calculated for responses, not for missing or unevaluable data. |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 28.9 | Not reported | NA | NA | 95% CIs were only calculated for responses, not for missing or unevaluable data. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 60.35
- upper Limit
- 73.80
- value
- 67.3
- group Id
- OG001
- lower Limit
- 53.07
- upper Limit
- 67.02
- value
- 60.2
- title
- Clinical Response Rate (CR+PR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.85
- upper Limit
- 46.86
- value
- 39.7
- group Id
- OG001
- lower Limit
- 18.16
- upper Limit
- 30.39
- value
- 23.9
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.55
- upper Limit
- 34.41
- value
- 27.6
- group Id
- OG001
- lower Limit
- 29.67
- upper Limit
- 43.38
- value
- 36.3
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.90
- upper Limit
- 11.52
- value
- 7.0
- group Id
- OG001
- lower Limit
- 6.18
- upper Limit
- 14.95
- value
- 10.0
- title
- Stable Disease (SD)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.01
- upper Limit
- 2.77
- value
- 0.5
- group Id
- OG001
- lower Limit
- 0.12
- upper Limit
- 3.55
- value
- 1.0
- title
- Progressive Disease (PD)
- categories
- measurements
- comment
- 95% CIs were only calculated for responses, not for missing or unevaluable data.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 25.1
- comment
- 95% CIs were only calculated for responses, not for missing or unevaluable data.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 28.9
- title
- Missing or Unevaluable
- denoms
- counts
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 201
- units
- Participants
- description
- The clinical response rate was defined as the percentage of participants in the ITT population who achieved a complete response (CR) or partial response (PR) prior to surgery, according to RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. Participants were classified as missing or unevaluable if no assessments were measured prior to surgery on the ipsilateral breast. The 95% CIs were calculated using the Clopper-Pearson method; they were only calculated for responses (not for missing or unevaluable data).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
- id
- OG000
- title
- Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
- description
- Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
- id
- OG001
- title
- Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
- param Type
- NUMBER
- population Description
- ITT population: included all participants who were enrolled regardless of whether they received any study treatment, grouped according to the arm to which a participant was enrolled.
- reporting Status
- POSTED
- time Frame
- From Baseline until disease progression or death due to any cause up to 24 weeks (during the neoadjuvant treatment period; assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks])
- title
- Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice