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NCT00074152 · OUTCOME

Sites of First Failures

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer · Source last updated 2017-06-16

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
5 years after randomization

What was measured

Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow

Groups in this outcome

Arm I

Observation (+/- Radiation).Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery

Arm II

Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.

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 I77
Arm II85

Reported measurements

Failures
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I34Not reportedNot reportedNot reportedNot reported
Arm II24Not reportedNot reportedNot reportedNot reported
Deaths
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I21Not reportedNot reportedNot reportedNot reported
Arm II9Not reportedNot reportedNot reportedNot reported
Local or Regional
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I9Not reportedNot reportedNot reportedNot reported
Arm II6Not reportedNot reportedNot reportedNot reported
Distant
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I22Not reportedNot reportedNot reportedNot reported
Arm II15Not reportedNot reportedNot reportedNot reported
Soft Tissue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I2Not reportedNot reportedNot reportedNot reported
Arm II0Not reportedNot reportedNot reportedNot reported
Bone
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I5Not reportedNot reportedNot reportedNot reported
Arm II8Not reportedNot reportedNot reportedNot reported
Viscera
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I15Not reportedNot reportedNot reportedNot reported
Arm II7Not reportedNot reportedNot reportedNot reported
Contralateral Breast
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Arm II1Not reportedNot reportedNot reportedNot reported
Secon (non-breast) Malignancy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I0Not reportedNot reportedNot reportedNot reported
Arm II1Not reportedNot reportedNot reportedNot reported
Death without prior Cancer Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I0Not reportedNot reportedNot reportedNot reported
Arm II1Not reportedNot reportedNot reportedNot reported
Death, cause unknown
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I2Not reportedNot reportedNot reportedNot reported
Arm II0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        24
    title
    Failures
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        9
    title
    Deaths
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
    title
    Local or Regional
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        15
    title
    Distant
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Soft Tissue
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
    title
    Bone
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        7
    title
    Viscera
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Contralateral Breast
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Secon (non-breast) Malignancy
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Death without prior Cancer Event
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Death, cause unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      77
    2. group Id
      OG001
      value
      85
    units
    Participants
description
Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow
groups
  1. description
    Observation (+/- Radiation).Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
    id
    OG000
    title
    Arm I
  2. description
    Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
    id
    OG001
    title
    Arm II
param Type
NUMBER
reporting Status
POSTED
time Frame
5 years after randomization
title
Sites of First Failures
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice