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NCT00542451 · OUTCOME

Number of Patients With Amenorrhea

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive 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
Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression.

What was measured

Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.

Analysis population: 64 women are evaluable for the amenorrhea assessment

Groups in this outcome

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.

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

Analysis denominator · Participants

GroupSource count
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer64

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    units
    Participants
description
Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.
groups
  1. description
    80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
    id
    OG000
    title
    Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
param Type
COUNT_OF_PARTICIPANTS
population Description
64 women are evaluable for the amenorrhea assessment
reporting Status
POSTED
time Frame
Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression.
title
Number of Patients With Amenorrhea
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice