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NCT00861705 · OUTCOME

Radiographic Response Assessed by Tumor Measurement

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline; at completion of neoadjuvant therapy

What was measured

Assessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.

Groups in this outcome

Arm 1 (Pac --> ddAC)

Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV

Arm 2 (Pac + Bev --> ddAC + Bev)

Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV

Arm 3 (Pac + Carboplatin --> ddAC)

Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV

Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)

Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV

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

Analysis denominator · Participants

GroupSource count
Arm 1 (Pac --> ddAC)108
Arm 2 (Pac + Bev --> ddAC + Bev)110
Arm 3 (Pac + Carboplatin --> ddAC)112
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)112

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)11Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)12Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)19Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)13Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)16Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)11Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)16Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)17Not reportedNot reportedNot reportedNot reported

Failures

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)81Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)87Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)77Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)82Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        19
      4. group Id
        OG003
        value
        13
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        17
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        81
      2. group Id
        OG001
        value
        87
      3. group Id
        OG002
        value
        77
      4. group Id
        OG003
        value
        82
      title
      Failures
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      110
    3. group Id
      OG002
      value
      112
    4. group Id
      OG003
      value
      112
    units
    Participants
description
Assessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.
groups
  1. description
    Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV
    id
    OG000
    title
    Arm 1 (Pac --> ddAC)
  2. description
    Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV
    id
    OG001
    title
    Arm 2 (Pac + Bev --> ddAC + Bev)
  3. description
    Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
    id
    OG002
    title
    Arm 3 (Pac + Carboplatin --> ddAC)
  4. description
    Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
    id
    OG003
    title
    Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline; at completion of neoadjuvant therapy
title
Radiographic Response Assessed by Tumor Measurement
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice