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NCT00545688 · OUTCOME

Percentage of Participants Achieving Pathological Complete Response (pCR)

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 with invalid/missing pCR assessments were defined as non-responders

Analysis population: ITT Population; Analysis was performed according to initial randomization.

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab+Docetaxel29.0Not reported20.638.5Not reported
Trastuzumab+Pertuzumab+Docetaxel45.8Not reported36.155.7Not reported
Trastuzumab+Pertuzumab16.8Not reported10.325.3Not reported
Pertuzumab+Docetaxel24.0Not reported15.833.7Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    3.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    30.1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0094
    p Value Comment
    Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).
    param Type
    Difference in Response rates
    param Value
    16.82
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0141
    p Value Comment
    P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
    statistical Method
    Cochran-Mantel-Haenszel
  3. ci Lower Limit
    -23.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.5
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0198
    p Value Comment
    Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).
    param Type
    Difference in Response rates
    param Value
    -12.15
    statistical Method
    Cochran-Mantel-Haenszel
  4. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0198
    p Value Comment
    P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
    statistical Method
    Cochran-Mantel-Haenszel
  5. ci Lower Limit
    -35.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -8.5
    group Ids
    1. OG001
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    p Value Comment
    Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).
    param Type
    Difference in Response rates
    param Value
    -21.84
    statistical Method
    Cochran-Mantel-Haenszel
  6. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0030
    p Value Comment
    P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    3.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    30.1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0094
    p Value Comment
    Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).
    param Type
    Difference in Response rates
    param Value
    16.82
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0141
    p Value Comment
    P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
    statistical Method
    Cochran-Mantel-Haenszel
  3. ci Lower Limit
    -23.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.5
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0198
    p Value Comment
    Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).
    param Type
    Difference in Response rates
    param Value
    -12.15
    statistical Method
    Cochran-Mantel-Haenszel
  4. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0198
    p Value Comment
    P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
    statistical Method
    Cochran-Mantel-Haenszel
  5. ci Lower Limit
    -35.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -8.5
    group Ids
    1. OG001
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    p Value Comment
    Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).
    param Type
    Difference in Response rates
    param Value
    -21.84
    statistical Method
    Cochran-Mantel-Haenszel
  6. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0030
    p Value Comment
    P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.6
        upper Limit
        38.5
        value
        29.0
      2. group Id
        OG001
        lower Limit
        36.1
        upper Limit
        55.7
        value
        45.8
      3. group Id
        OG002
        lower Limit
        10.3
        upper Limit
        25.3
        value
        16.8
      4. group Id
        OG003
        lower Limit
        15.8
        upper Limit
        33.7
        value
        24.0
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 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.
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 Pathological Complete Response (pCR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice