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NCT02445391 · OUTCOME

Health-related Quality of Life (HRQL) at 6-month Assessment

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy · Source last updated 2026-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Assessed at 6 months after randomization

What was measured

HRQL was measured by the Functional Assessment of Cancer Therapy Breast Symptom Index (FBSI) Treatment Side Effects (TSE) subscale score, an aggregate score of 4 items (GP2, GP5, N6 and B5) from the FBSI-16 scale. The FBSI TSE subscale score was calculated based on the scoring manual, score ranges from 0 to 16, higher scores indicate better quality of life.

Analysis population: All patients randomized to arms B and C and reported health-related quality of life data at 6-month assessment

Groups in this outcome

Arm B (Cisplatin or Carboplatin)

Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV

Arm C (Capecitabine) (Open to Accrual 6/22/2016)

Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO

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 B (Cisplatin or Carboplatin)69
Arm C (Capecitabine) (Open to Accrual 6/22/2016)84

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B (Cisplatin or Carboplatin)14.71.8Not reportedNot reportedNot reported
Arm C (Capecitabine) (Open to Accrual 6/22/2016)14.61.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.8
        value
        14.7
      2. group Id
        OG001
        spread
        1.7
        value
        14.6
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      84
    units
    Participants
description
HRQL was measured by the Functional Assessment of Cancer Therapy Breast Symptom Index (FBSI) Treatment Side Effects (TSE) subscale score, an aggregate score of 4 items (GP2, GP5, N6 and B5) from the FBSI-16 scale. The FBSI TSE subscale score was calculated based on the scoring manual, score ranges from 0 to 16, higher scores indicate better quality of life.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
    id
    OG000
    title
    Arm B (Cisplatin or Carboplatin)
  2. description
    Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
    id
    OG001
    title
    Arm C (Capecitabine) (Open to Accrual 6/22/2016)
param Type
MEAN
population Description
All patients randomized to arms B and C and reported health-related quality of life data at 6-month assessment
reporting Status
POSTED
time Frame
Assessed at 6 months after randomization
title
Health-related Quality of Life (HRQL) at 6-month Assessment
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice