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NCT03493854 · OUTCOME

Number of Participants With a Primary Cardiac Event During the Neoadjuvant Phase

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-06-26

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 first dose of study treatment until the completion of neoadjuvant therapy (24 weeks)

What was measured

A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event \[e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia\] without documented etiology).

Analysis population: Safety Population: includes all participants who received at least one dose of study medication.

Groups in this outcome

Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy

Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.

Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy

Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy252
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy248

Reported measurements

Any Primary Cardiac Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy0Not reportedNot reportedNot reportedNot reported
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy2Not reportedNot reportedNot reportedNot reported
Heart Failure and Significant LVEF Decline
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy0Not reportedNot reportedNot reportedNot reported
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy1Not reportedNot reportedNot reportedNot reported
Cardiac Death (Definite or Probable)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy0Not reportedNot reportedNot reportedNot reported
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Any Primary Cardiac Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Heart Failure and Significant LVEF Decline
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Cardiac Death (Definite or Probable)
denoms
  1. counts
    1. group Id
      OG000
      value
      252
    2. group Id
      OG001
      value
      248
    units
    Participants
description
A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event \[e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia\] without documented etiology).
groups
  1. description
    Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
    id
    OG000
    title
    Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
  2. description
    Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
    id
    OG001
    title
    Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population: includes all participants who received at least one dose of study medication.
reporting Status
POSTED
time Frame
From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks)
title
Number of Participants With a Primary Cardiac Event During the Neoadjuvant Phase
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice