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NCT00861705 · OUTCOME

Clinical 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 Response Evaluation Criteria in Solid Tumors (RECIST). Both target and, in the event of multifocal or multicentric invasive breast cancer, nontarget lesions should be followed clinically and their clinical size recorded at aseline. Measurements thereafter are required at the completion of 12 weeks of paclitaxel or paclitaxel/carboplatin and at the completion of all neoadjuvant chemotherapy. At any time point, these lesions should be categorized regarding whether there is evidence of progression. If "yes", the study chair should be notified in order to determine whether the patient should come off protocol treatment. In-situcarcinoma does not represent a non-target lesion and should not be recorded or followed.

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)28Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)35Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)45Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)40Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)37Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)38Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)36Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)37Not reportedNot reportedNot reportedNot reported

Failures

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)43Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)37Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)31Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)35Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        35
      3. group Id
        OG002
        value
        45
      4. group Id
        OG003
        value
        40
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        36
      4. group Id
        OG003
        value
        37
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        31
      4. group Id
        OG003
        value
        35
      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 Response Evaluation Criteria in Solid Tumors (RECIST). Both target and, in the event of multifocal or multicentric invasive breast cancer, nontarget lesions should be followed clinically and their clinical size recorded at aseline. Measurements thereafter are required at the completion of 12 weeks of paclitaxel or paclitaxel/carboplatin and at the completion of all neoadjuvant chemotherapy. At any time point, these lesions should be categorized regarding whether there is evidence of progression. If "yes", the study chair should be notified in order to determine whether the patient should come off protocol treatment. In-situcarcinoma does not represent a non-target lesion and should not be recorded or followed.
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
Clinical Response Assessed by Tumor Measurement
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice