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NCT00861705 · OUTCOME

Recurrence-free Survival

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
up to 10 years

What was measured

From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause. Number of Participants who Died Due to Any Cause or had a recurrence.

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

With event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)32Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)34Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)37Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)27Not reportedNot reportedNot reportedNot reported

Without event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (Pac --> ddAC)76Not reportedNot reportedNot reportedNot reported
Arm 2 (Pac + Bev --> ddAC + Bev)76Not reportedNot reportedNot reportedNot reported
Arm 3 (Pac + Carboplatin --> ddAC)75Not reportedNot reportedNot reportedNot reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)85Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.75
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.08
  2. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.92
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.20
  3. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    0.82
Complete source fields
analyses
  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.75
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.08
  2. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.92
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.20
  3. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    0.82
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        34
      3. group Id
        OG002
        value
        37
      4. group Id
        OG003
        value
        27
      title
      With event
    2. measurements
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        76
      3. group Id
        OG002
        value
        75
      4. group Id
        OG003
        value
        85
      title
      Without event
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
From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause. Number of Participants who Died Due to Any Cause or had a recurrence.
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
up to 10 years
title
Recurrence-free Survival
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice