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NCT00861705 · OUTCOME

Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)

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
participants
Interval / dispersion
Not reported
Time frame
at definitive surgery, up to 28 weeks

What was measured

Stage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.

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)107
Arm 2 (Pac + Bev --> ddAC + Bev)105
Arm 3 (Pac + Carboplatin --> ddAC)111
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)110

Reported measurements

Breast : Stage II
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)42Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)49Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)51Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)70Not reportedNot reportedNot reportedNot reported
Breast : Stage III
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)42Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)55Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)57Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)62Not reportedNot reportedNot reportedNot reported
Breast/Axilla : Stage II
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)41Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)42Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)47Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)63Not reportedNot reportedNot reportedNot reported
Breast/Axilla : Stage III
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)36Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)45Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)51Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)54Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        51
      4. group Id
        OG003
        value
        70
    title
    Breast : Stage II
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        55
      3. group Id
        OG002
        value
        57
      4. group Id
        OG003
        value
        62
    title
    Breast : Stage III
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        42
      3. group Id
        OG002
        value
        47
      4. group Id
        OG003
        value
        63
    title
    Breast/Axilla : Stage II
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        45
      3. group Id
        OG002
        value
        51
      4. group Id
        OG003
        value
        54
    title
    Breast/Axilla : Stage III
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    2. group Id
      OG001
      value
      105
    3. group Id
      OG002
      value
      111
    4. group Id
      OG003
      value
      110
    units
    Participants
description
Stage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.
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
NUMBER
reporting Status
POSTED
time Frame
at definitive surgery, up to 28 weeks
title
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice