TriangleNCT02132949 · OUTCOME
Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From 42 days after the last dose of study treatment until the end of treatment-free follow-up (TFFU; up to 5 years)
What was measured
An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), and a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness were independently assessed for each AE. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as ejection fraction decreased). During TFFU, only heart failure, pregnancies, and non-breast-related second primary malignancies, irrespective of causal relationship with study treatment, and drug-related SAEs were reported. Multiple occurrences of the same AE in 1 subject were counted only once.
Analysis population: Safety analysis population of all participants who received any study treatment during the study, grouped according to treatment received.
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 | 198 |
Reported measurements
Any Adverse Event (AE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 7 | Not reported | Not reported | Not reported | Not reported |
NCI-CTCAE Grade 3-5 AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 5 | Not reported | Not reported | Not reported | Not reported |
Serious AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 7 | Not reported | Not reported | Not reported | Not reported |
Deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 13 | Not reported | Not reported | Not reported | Not reported |
Ejection Fraction Decreased (Any Grade)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
Heart Failure (Any Grade)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- title
- Any Adverse Event (AE)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- title
- NCI-CTCAE Grade 3-5 AE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- title
- Serious AE
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 13
- title
- Deaths
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Ejection Fraction Decreased (Any Grade)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Heart Failure (Any Grade)
- denoms
- counts
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 198
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), and a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness were independently assessed for each AE. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as ejection fraction decreased). During TFFU, only heart failure, pregnancies, and non-breast-related second primary malignancies, irrespective of causal relationship with study treatment, and drug-related SAEs were reported. Multiple occurrences of the same AE in 1 subject were counted only once.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis population of all participants who received any study treatment during the study, grouped according to treatment received.
- reporting Status
- POSTED
- time Frame
- From 42 days after the last dose of study treatment until the end of treatment-free follow-up (TFFU; up to 5 years)
- title
- Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice