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NCT00976989 · OUTCOME

Efficacy: Percentage of Participants Achieving Breast Conserving Surgery

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer · Source last updated 2017-02-06

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
Not reported
Time frame
At approximately 18 weeks

What was measured

This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.

Analysis population: Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.

Groups in this outcome

T+P Concomitant Anthracycline-based Chemotherapy

5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.

T+P Sequential Anthracycline-based Chemotherapy

FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.

T+P Concomitant Non-Anthracycline Chemotherapy

Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-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
T+P Concomitant Anthracycline-based Chemotherapy46
T+P Sequential Anthracycline-based Chemotherapy36
T+P Concomitant Non-Anthracycline Chemotherapy37

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T+P Concomitant Anthracycline-based Chemotherapy21.7Not reportedNot reportedNot reportedNot reported
T+P Sequential Anthracycline-based Chemotherapy16.7Not reportedNot reportedNot reportedNot reported
T+P Concomitant Non-Anthracycline Chemotherapy27.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21.7
      2. group Id
        OG001
        value
        16.7
      3. group Id
        OG002
        value
        27.0
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      36
    3. group Id
      OG002
      value
      37
    units
    Participants
description
This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.
groups
  1. description
    5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
    id
    OG000
    title
    T+P Concomitant Anthracycline-based Chemotherapy
  2. description
    FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
    id
    OG001
    title
    T+P Sequential Anthracycline-based Chemotherapy
  3. description
    Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
    id
    OG002
    title
    T+P Concomitant Non-Anthracycline Chemotherapy
param Type
NUMBER
population Description
Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.
reporting Status
POSTED
time Frame
At approximately 18 weeks
title
Efficacy: Percentage of Participants Achieving Breast Conserving Surgery
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice