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NCT02132949 · OUTCOME

Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period

A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer · Source last updated 2021-09-17

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 the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)

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 with respect to an AE. 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), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs.

Analysis population: Safety analysis population of all participants who started and received any study treatment during the adjuvant treatment period, 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab181
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab190

Reported measurements

Any Adverse Event (AE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab171Not reportedNot reportedNot reportedNot reported
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab171Not reportedNot reportedNot reportedNot reported
NCI-CTCAE Grade 3-5 AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab23Not reportedNot reportedNot reportedNot reported
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab40Not reportedNot reportedNot reportedNot reported
Serious AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab15Not reportedNot reportedNot reportedNot reported
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab17Not reportedNot reportedNot reportedNot reported
Deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab0Not reportedNot reportedNot reportedNot reported
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab0Not reportedNot reportedNot reportedNot reported
Ejection Fraction Decreased (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab15Not reportedNot reportedNot reportedNot reported
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab20Not reportedNot reportedNot reportedNot reported
Heart Failure (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab0Not reportedNot reportedNot reportedNot reported
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        171
      2. group Id
        OG001
        value
        171
    title
    Any Adverse Event (AE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        40
    title
    NCI-CTCAE Grade 3-5 AE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        17
    title
    Serious AE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Deaths
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        20
    title
    Ejection Fraction Decreased (Any Grade)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Heart Failure (Any Grade)
denoms
  1. counts
    1. group Id
      OG000
      value
      181
    2. group Id
      OG001
      value
      190
    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 with respect to an AE. 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), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs.
groups
  1. 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
  2. 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 started and received any study treatment during the adjuvant treatment period, grouped according to treatment received.
reporting Status
POSTED
time Frame
From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)
title
Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice