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NCT00545688 · OUTCOME

Percentage of Participants Achieving pCR by Hormone Receptor Status

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer. · Source last updated 2017-08-15

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
95% Confidence Interval
Time frame
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)

What was measured

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.

Analysis population: ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.

Groups in this outcome

Trastuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.

Trastuzumab+Pertuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.

Trastuzumab+Pertuzumab

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.

Pertuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.

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

Analysis denominator · Participants

GroupSource count
Trastuzumab+Docetaxel107
Trastuzumab+Pertuzumab+Docetaxel107
Trastuzumab+Pertuzumab107
Pertuzumab+Docetaxel96

Reported measurements

Estrogen and/or Progesterone +ve (n=50,50,51,46)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab+Docetaxel20.0Not reported10.033.7Not reported
Trastuzumab+Pertuzumab+Docetaxel26.0Not reported14.640.3Not reported
Trastuzumab+Pertuzumab5.9Not reported1.216.2Not reported
Pertuzumab+Docetaxel17.4Not reported7.831.4Not reported
Estrogen and/or Progesterone -ve (n=57,57,55,50)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab+Docetaxel36.8Not reported24.450.7Not reported
Trastuzumab+Pertuzumab+Docetaxel63.2Not reported49.375.6Not reported
Trastuzumab+Pertuzumab27.3Not reported16.141.0Not reported
Pertuzumab+Docetaxel30.0Not reported17.944.6Not reported
Receptor Status Unknown (0,0,1,0)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab+DocetaxelNANot reportedNANAThere were no participants in this category.
Trastuzumab+Pertuzumab+DocetaxelNANot reportedNANAThere were no participants in this category.
Trastuzumab+Pertuzumab0.0Not reported0.097.5Not reported
Pertuzumab+DocetaxelNANot reportedNANAThere were no participants in this category.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.0
        upper Limit
        33.7
        value
        20.0
      2. group Id
        OG001
        lower Limit
        14.6
        upper Limit
        40.3
        value
        26.0
      3. group Id
        OG002
        lower Limit
        1.2
        upper Limit
        16.2
        value
        5.9
      4. group Id
        OG003
        lower Limit
        7.8
        upper Limit
        31.4
        value
        17.4
    title
    Estrogen and/or Progesterone +ve (n=50,50,51,46)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.4
        upper Limit
        50.7
        value
        36.8
      2. group Id
        OG001
        lower Limit
        49.3
        upper Limit
        75.6
        value
        63.2
      3. group Id
        OG002
        lower Limit
        16.1
        upper Limit
        41.0
        value
        27.3
      4. group Id
        OG003
        lower Limit
        17.9
        upper Limit
        44.6
        value
        30.0
    title
    Estrogen and/or Progesterone -ve (n=57,57,55,50)
  3. categories
    1. measurements
      1. comment
        There were no participants in this category.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        There were no participants in this category.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
      4. comment
        There were no participants in this category.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Receptor Status Unknown (0,0,1,0)
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    2. group Id
      OG001
      value
      107
    3. group Id
      OG002
      value
      107
    4. group Id
      OG003
      value
      96
    units
    Participants
description
pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.
dispersion Type
95% Confidence Interval
groups
  1. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
    id
    OG000
    title
    Trastuzumab+Docetaxel
  2. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
    id
    OG001
    title
    Trastuzumab+Pertuzumab+Docetaxel
  3. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
    id
    OG002
    title
    Trastuzumab+Pertuzumab
  4. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
    id
    OG003
    title
    Pertuzumab+Docetaxel
param Type
NUMBER
population Description
ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.
reporting Status
POSTED
time Frame
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
title
Percentage of Participants Achieving pCR by Hormone Receptor Status
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice