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NCT00861705 · OUTCOME

Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).

Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery · Source last updated 2026-06-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants with pCR
Interval / dispersion
95% Confidence Interval
Time frame
At the time of definitive surgical removal, up to 28 weeks

What was measured

Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.

Analysis population: All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).

Groups in this outcome

Factor A: Carboplatin

Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).

Factor A: No Carboplatin

Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).

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

Analysis denominator · Participants

GroupSource count
Factor A: Carboplatin221
Factor A: No Carboplatin212

Reported measurements

Source class 1
Values in percentage of participants with pCR · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Factor A: Carboplatin60Not reported5466Not reported
Factor A: No Carboplatin46Not reported4053Not reported

Source statistical analyses

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

  1. group Description
    The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0018
    statistical Comment
    Reported p-values are unadjusted and 1-sided
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0018
    statistical Comment
    Reported p-values are unadjusted and 1-sided
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54
        upper Limit
        66
        value
        60
      2. group Id
        OG001
        lower Limit
        40
        upper Limit
        53
        value
        46
denoms
  1. counts
    1. group Id
      OG000
      value
      221
    2. group Id
      OG001
      value
      212
    units
    Participants
description
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
dispersion Type
95% Confidence Interval
groups
  1. description
    Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
    id
    OG000
    title
    Factor A: Carboplatin
  2. description
    Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
    id
    OG001
    title
    Factor A: No Carboplatin
param Type
NUMBER
population Description
All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).
reporting Status
POSTED
time Frame
At the time of definitive surgical removal, up to 28 weeks
title
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
type
PRIMARY
unit Of Measure
percentage of participants with pCR

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

Preserved source evidence · Not medical advice