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NCT02445391 · OUTCOME

3-year Overall Survival (OS) Rate in Basal-Subtype Patients

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years

What was measured

OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method.

Analysis population: The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).

Groups in this outcome

Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)

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) (Enrolled While Arm C Was Open)148
Arm C (Capecitabine) (Open to Accrual 6/22/2016)160

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)57.8Not reported45.268.4Not reported
Arm C (Capecitabine) (Open to Accrual 6/22/2016)66.2Not reported56.374.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.2
        upper Limit
        68.4
        value
        57.8
      2. group Id
        OG001
        lower Limit
        56.3
        upper Limit
        74.3
        value
        66.2
denoms
  1. counts
    1. group Id
      OG000
      value
      148
    2. group Id
      OG001
      value
      160
    units
    Participants
description
OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
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) (Enrolled While Arm C Was Open)
  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
NUMBER
population Description
The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).
reporting Status
POSTED
time Frame
Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years
title
3-year Overall Survival (OS) Rate in Basal-Subtype Patients
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice