Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00513292 · OUTCOME

Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12

Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery · Source last updated 2019-01-23

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
Not reported
Time frame
Baseline, at 12 week

What was measured

The summary of asymptomatic decrease in LVEF.

Analysis population: All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.

Groups in this outcome

FEC-75 Then Paclitaxel/Trastuzumab

Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies

Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75

Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
FEC-75 Then Paclitaxel/Trastuzumab130
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75137

Reported measurements

no decrease or decrease < 10%, still above LLN
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FEC-75 Then Paclitaxel/Trastuzumab92.3Not reportedNot reportedNot reportedNot reported
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-7582.5Not reportedNot reportedNot reportedNot reported
decrease < 10%, below lower limit of normal (LLN)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FEC-75 Then Paclitaxel/Trastuzumab0.8Not reportedNot reportedNot reportedNot reported
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-750Not reportedNot reportedNot reportedNot reported
decrease 10-15%, still above lower limit of normal
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FEC-75 Then Paclitaxel/Trastuzumab6.2Not reportedNot reportedNot reportedNot reported
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-7511.7Not reportedNot reportedNot reportedNot reported
decrease 10-15%, below lower limit of normal (LLN)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FEC-75 Then Paclitaxel/Trastuzumab0Not reportedNot reportedNot reportedNot reported
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-750Not reportedNot reportedNot reportedNot reported
decrease > 15%, still above lower limit of norm
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FEC-75 Then Paclitaxel/Trastuzumab0.8Not reportedNot reportedNot reportedNot reported
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-752.9Not reportedNot reportedNot reportedNot reported
decrease > 15%, below lower limit of normal
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FEC-75 Then Paclitaxel/Trastuzumab0Not reportedNot reportedNot reportedNot reported
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-752.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        92.3
      2. group Id
        OG001
        value
        82.5
    title
    no decrease or decrease < 10%, still above LLN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.8
      2. group Id
        OG001
        value
        0
    title
    decrease < 10%, below lower limit of normal (LLN)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6.2
      2. group Id
        OG001
        value
        11.7
    title
    decrease 10-15%, still above lower limit of normal
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    decrease 10-15%, below lower limit of normal (LLN)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.8
      2. group Id
        OG001
        value
        2.9
    title
    decrease > 15%, still above lower limit of norm
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2.9
    title
    decrease > 15%, below lower limit of normal
denoms
  1. counts
    1. group Id
      OG000
      value
      130
    2. group Id
      OG001
      value
      137
    units
    Participants
description
The summary of asymptomatic decrease in LVEF.
groups
  1. description
    Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    FEC-75 Then Paclitaxel/Trastuzumab
  2. description
    Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
    id
    OG001
    title
    Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
param Type
NUMBER
population Description
All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.
reporting Status
POSTED
time Frame
Baseline, at 12 week
title
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice