Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01853748 · OUTCOME

Percentage of Patients With Amenorrhea

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) · Source last updated 2026-02-19

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
Surveys are took at month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

What was measured

All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade \>=3 AE of any type during the time of observation. For those who were premenopausal pre-chemotherapy, at each follow-up visit (every six months) in order to assess for duration of amenorrhea and also premature ovarian failure.

Groups in this outcome

Trastuzumab Emtansine (T-DM1)

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

Paclitaxel + Trastuzumab (TH)

paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine (T-DM1)383
Paclitaxel + Trastuzumab (TH)114

Reported measurements

6 months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)80Not reportedNot reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)21Not reportedNot reportedNot reportedNot reported
1 year
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)71Not reportedNot reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)22Not reportedNot reportedNot reportedNot reported
18 months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)64Not reportedNot reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)20Not reportedNot reportedNot reportedNot reported
24 months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)74Not reportedNot reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)15Not reportedNot reportedNot reportedNot reported
30 months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)60Not reportedNot reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)11Not reportedNot reportedNot reportedNot reported
36 months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine (T-DM1)45Not reportedNot reportedNot reportedNot reported
Paclitaxel + Trastuzumab (TH)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        21
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        22
    title
    1 year
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        20
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        15
    title
    24 months
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        11
    title
    30 months
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        9
    title
    36 months
denoms
  1. counts
    1. group Id
      OG000
      value
      383
    2. group Id
      OG001
      value
      114
    units
    Participants
description
All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade \>=3 AE of any type during the time of observation. For those who were premenopausal pre-chemotherapy, at each follow-up visit (every six months) in order to assess for duration of amenorrhea and also premature ovarian failure.
groups
  1. description
    T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
    id
    OG000
    title
    Trastuzumab Emtansine (T-DM1)
  2. description
    paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
    id
    OG001
    title
    Paclitaxel + Trastuzumab (TH)
param Type
NUMBER
reporting Status
POSTED
time Frame
Surveys are took at month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.
title
Percentage of Patients With Amenorrhea
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice