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NCT01772472 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

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: Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)

What was measured

The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), a global health status/quality of life (GHS/QoL) scale, three symptom scales (fatigue, pain, nausea, and vomiting), five single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and a perceived financial impact of the disease item. Most questions used a 4-point scale (1= Not at all to 4 = Very much; 2 questions used a 7-point scale \[1 = very poor to 7 = Excellent\]). Obtained scores are linearly transformed to a score range of 0-100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms. A positive change from baseline indicates improvement.

Analysis population: ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.

Groups in this outcome

Trastuzumab

Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

Trastuzumab Emtansine

Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

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

Analysis denominator · Participants

Group	Source count
Trastuzumab	743
Trastuzumab Emtansine	743

Reported measurements

Baseline: Appetite Loss

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	7.9	17.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	7.1	16.4	Not reported	Not reported	Not reported

Change at Cycle 5: Appetite Loss

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.0	18.7	Not reported	Not reported	Not reported
Trastuzumab Emtansine	6.5	23.7	Not reported	Not reported	Not reported

Change at Cycle 11: Appetite Loss

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-0.5	17.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	2.9	20.2	Not reported	Not reported	Not reported

Change at FU Month 6: Appetite Loss

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-1.6	18.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.7	19.9	Not reported	Not reported	Not reported

Change at FU Month 12: Appetite Loss

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.5	20.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.9	20.1	Not reported	Not reported	Not reported

Baseline: Constipation

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	9.8	20.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	9.5	19.0	Not reported	Not reported	Not reported

Change at Cycle 5: Constipation

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.0	22.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	4.6	22.6	Not reported	Not reported	Not reported

Change at Cycle 11: Constipation

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	3.4	23.6	Not reported	Not reported	Not reported
Trastuzumab Emtansine	7.3	23.1	Not reported	Not reported	Not reported

Change at FU Month 6: Constipation

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	4.1	23.7	Not reported	Not reported	Not reported
Trastuzumab Emtansine	3.7	23.3	Not reported	Not reported	Not reported

Change at FU Month 12: Constipation

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	3.2	23.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	4.3	24.6	Not reported	Not reported	Not reported

Baseline: Diarrhea

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	8.8	17.6	Not reported	Not reported	Not reported
Trastuzumab Emtansine	6.4	14.9	Not reported	Not reported	Not reported

Change at Cycle 5: Diarrhea

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-1.6	19.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.5	19.5	Not reported	Not reported	Not reported

Change at Cycle 11: Diarrhea

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-0.4	21.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-2.4	17.5	Not reported	Not reported	Not reported

Change at FU Month 6: Diarrhea

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-3.4	18.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.9	18.3	Not reported	Not reported	Not reported

Change at FU Month 12: Diarrhea

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-2.8	18.9	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.6	18.4	Not reported	Not reported	Not reported

Baseline: Dyspnea

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	12.7	20.7	Not reported	Not reported	Not reported
Trastuzumab Emtansine	11.0	18.8	Not reported	Not reported	Not reported

Change at Cycle 5: Dyspnea

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	2.3	21.9	Not reported	Not reported	Not reported
Trastuzumab Emtansine	4.1	22.4	Not reported	Not reported	Not reported

Change at Cycle 11: Dyspnea

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	2.8	21.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	2.7	20.4	Not reported	Not reported	Not reported

Change at FU Month 6: Dyspnea

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	3.3	22.8	Not reported	Not reported	Not reported
Trastuzumab Emtansine	3.8	22.7	Not reported	Not reported	Not reported

Change at FU Month 12: Dyspnea

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	3.9	24.9	Not reported	Not reported	Not reported
Trastuzumab Emtansine	5.3	22.4	Not reported	Not reported	Not reported

Baseline: Fatigue

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	29.2	21.1	Not reported	Not reported	Not reported
Trastuzumab Emtansine	28.0	20.0	Not reported	Not reported	Not reported

Change at Cycle 5: Fatigue

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.1	20.1	Not reported	Not reported	Not reported
Trastuzumab Emtansine	5.5	19.7	Not reported	Not reported	Not reported

Change at Cycle 11: Fatigue

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.1	20.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	3.8	21.3	Not reported	Not reported	Not reported

Change at FU Month 6: Fatigue

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-1.4	21.9	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.1	22.2	Not reported	Not reported	Not reported

Change at FU Month 12: Fatigue

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-0.1	23.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.1	22.1	Not reported	Not reported	Not reported

Baseline: Financial Difficulties

Analysis denominator · Participants

Group	Source count
Trastuzumab	604
Trastuzumab Emtansine	635

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	28.6	33.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	27.6	31.9	Not reported	Not reported	Not reported

Change at Cycle 5: Financial Difficulties

Analysis denominator · Participants

Group	Source count
Trastuzumab	530
Trastuzumab Emtansine	548

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-3.1	26.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-3.0	28.0	Not reported	Not reported	Not reported

Change at Cycle 11: Financial Difficulties

Analysis denominator · Participants

Group	Source count
Trastuzumab	472
Trastuzumab Emtansine	480

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-5.1	27.6	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.7	28.7	Not reported	Not reported	Not reported

Change at FU Month 6: Financial Difficulties

Analysis denominator · Participants

Group	Source count
Trastuzumab	393
Trastuzumab Emtansine	444

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-8.4	28.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-6.5	30.6	Not reported	Not reported	Not reported

Change at FU Month 12: Financial Difficulties

Analysis denominator · Participants

Group	Source count
Trastuzumab	367
Trastuzumab Emtansine	413

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-10.9	30.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-7.3	31.0	Not reported	Not reported	Not reported

Baseline: Insomnia

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	30.6	30.8	Not reported	Not reported	Not reported
Trastuzumab Emtansine	30.6	29.2	Not reported	Not reported	Not reported

Change at Cycle 5: Insomnia

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.9	28.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	1.3	29.7	Not reported	Not reported	Not reported

Change at Cycle 11: Insomnia

Analysis denominator · Participants

Group	Source count
Trastuzumab	494
Trastuzumab Emtansine	494

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	2.4	29.9	Not reported	Not reported	Not reported
Trastuzumab Emtansine	1.5	30.3	Not reported	Not reported	Not reported

Change at FU Month 6: Insomnia

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.8	31.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.9	32.1	Not reported	Not reported	Not reported

Change at FU Month 12: Insomnia

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.3	30.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	0.7	31.7	Not reported	Not reported	Not reported

Baseline: Nausea/Vomiting

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	3.3	9.0	Not reported	Not reported	Not reported
Trastuzumab Emtansine	2.8	8.0	Not reported	Not reported	Not reported

Change at Cycle 5: Nausea/Vomiting

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.5	11.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	3.2	12.5	Not reported	Not reported	Not reported

Change at Cycle 11: Nausea/Vomiting

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.3	12.8	Not reported	Not reported	Not reported
Trastuzumab Emtansine	3.0	11.8	Not reported	Not reported	Not reported

Change at FU Month 6: Nausea/Vomiting

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.8	10.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	0.2	11.1	Not reported	Not reported	Not reported

Change at FU Month 12: Nausea/Vomiting

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.4	10.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	1.2	10.9	Not reported	Not reported	Not reported

Baseline: Pain

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	22.2	22.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	22.6	22.8	Not reported	Not reported	Not reported

Change at Cycle 5: Pain

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.0	23.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	1.8	23.9	Not reported	Not reported	Not reported

Change at Cycle 11: Pain

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.1	23.1	Not reported	Not reported	Not reported
Trastuzumab Emtansine	2.1	24.4	Not reported	Not reported	Not reported

Change at FU Month 6: Pain

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-0.3	24.6	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.5	24.3	Not reported	Not reported	Not reported

Change at FU Month 12: Pain

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-1.2	25.6	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.8	25.4	Not reported	Not reported	Not reported

Baseline: Cognitive Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	83.3	20.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	84.4	19.0	Not reported	Not reported	Not reported

Change at Cycle 5: Cognitive Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-3.8	18.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-4.5	18.7	Not reported	Not reported	Not reported

Change at Cycle 11: Cognitive Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-5.4	21.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-5.3	19.6	Not reported	Not reported	Not reported

Change at FU Month 6: Cognitive Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-4.1	22.0	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-6.1	21.6	Not reported	Not reported	Not reported

Change at FU Month 12: Cognitive Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-4.9	22.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-6.9	21.7	Not reported	Not reported	Not reported

Baseline: Emotional Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	75.0	22.0	Not reported	Not reported	Not reported
Trastuzumab Emtansine	75.2	21.2	Not reported	Not reported	Not reported

Change at Cycle 5: Emotional Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-0.4	20.0	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.3	21.3	Not reported	Not reported	Not reported

Change at Cycle 11: Emotional Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-1.0	21.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	0.1	22.0	Not reported	Not reported	Not reported

Change at FU Month 6: Emotional Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-2.9	22.0	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.8	23.3	Not reported	Not reported	Not reported

Change at FU Month 12: Emotional Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	-2.0	22.7	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.6	23.5	Not reported	Not reported	Not reported

Baseline: Physical Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	84.5	15.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	85.8	14.1	Not reported	Not reported	Not reported

Change at Cycle 5: Physical Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.3	12.9	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.6	12.7	Not reported	Not reported	Not reported

Change at Cycle 11: Physical Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.9	14.2	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.6	14.6	Not reported	Not reported	Not reported

Change at FU Month 6: Physical Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	2.8	15.4	Not reported	Not reported	Not reported
Trastuzumab Emtansine	0.7	15.1	Not reported	Not reported	Not reported

Change at FU Month 12: Physical Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	2.7	14.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	0.8	14.5	Not reported	Not reported	Not reported

Baseline: Role Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	77.5	25.0	Not reported	Not reported	Not reported
Trastuzumab Emtansine	78.6	23.3	Not reported	Not reported	Not reported

Change at Cycle 5: Role Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	2.0	24.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.2	24.1	Not reported	Not reported	Not reported

Change at Cycle 11: Role Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	4.0	24.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	0.6	24.5	Not reported	Not reported	Not reported

Change at FU Month 6: Role Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	7.4	25.8	Not reported	Not reported	Not reported
Trastuzumab Emtansine	3.6	26.7	Not reported	Not reported	Not reported

Change at FU Month 12: Role Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	8.0	27.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	4.6	25.5	Not reported	Not reported	Not reported

Baseline: Social Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	77.1	24.1	Not reported	Not reported	Not reported
Trastuzumab Emtansine	76.8	23.2	Not reported	Not reported	Not reported

Change at Cycle 5: Social Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	4.0	22.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	1.6	23.8	Not reported	Not reported	Not reported

Change at Cycle 11: Social Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	5.8	24.0	Not reported	Not reported	Not reported
Trastuzumab Emtansine	2.5	23.6	Not reported	Not reported	Not reported

Change at FU Month 6: Social Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	8.5	23.7	Not reported	Not reported	Not reported
Trastuzumab Emtansine	6.5	26.1	Not reported	Not reported	Not reported

Change at FU Month 12: Social Functioning

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	9.5	25.1	Not reported	Not reported	Not reported
Trastuzumab Emtansine	7.4	26.4	Not reported	Not reported	Not reported

Baseline: Global Health Status

Analysis denominator · Participants

Group	Source count
Trastuzumab	624
Trastuzumab Emtansine	645

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	71.2	19.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	71.4	18.0	Not reported	Not reported	Not reported

Change at Cycle 5: Global Health Status

Analysis denominator · Participants

Group	Source count
Trastuzumab	558
Trastuzumab Emtansine	571

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	0.6	18.9	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-1.9	19.6	Not reported	Not reported	Not reported

Change at Cycle 11: Global Health Status

Analysis denominator · Participants

Group	Source count
Trastuzumab	496
Trastuzumab Emtansine	496

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	1.7	17.8	Not reported	Not reported	Not reported
Trastuzumab Emtansine	-0.5	19.9	Not reported	Not reported	Not reported

Change at FU Month 6: Global Health Status

Analysis denominator · Participants

Group	Source count
Trastuzumab	410
Trastuzumab Emtansine	462

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	2.5	19.3	Not reported	Not reported	Not reported
Trastuzumab Emtansine	2.0	19.2	Not reported	Not reported	Not reported

Change at FU Month 12: Global Health Status

Analysis denominator · Participants

Group	Source count
Trastuzumab	384
Trastuzumab Emtansine	430

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	3.2	19.5	Not reported	Not reported	Not reported
Trastuzumab Emtansine	2.8	20.1	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
17.4
value
7.9
group Id
OG001
spread
16.4
value
7.1
denoms
counts
group Id
OG000
value
624
group Id
OG001
value
645
units
Participants
title
Baseline: Appetite Loss
categories
measurements
group Id
OG000
spread
18.7
value
1.0
group Id
OG001
spread
23.7
value
6.5
denoms
counts
group Id
OG000
value
558
group Id
OG001
value
571
units
Participants
title
Change at Cycle 5: Appetite Loss
categories
measurements
group Id
OG000
spread
17.2
value
-0.5
group Id
OG001
spread
20.2
value
2.9
denoms
counts
group Id
OG000
value
496
group Id
OG001
value
496
units
Participants
title
Change at Cycle 11: Appetite Loss
categories
measurements
group Id
OG000
spread
18.3
value
-1.6
group Id
OG001
spread
19.9
value
-1.7
denoms
counts
group Id
OG000
value
410
group Id
OG001
value
462
units
Participants
title
Change at FU Month 6: Appetite Loss
categories
measurements
group Id
OG000
spread
20.3
value
0.5
group Id
OG001
spread
20.1
value
-1.9
denoms
counts
group Id
OG000
value
384
group Id
OG001
value
430
units
Participants
title
Change at FU Month 12: Appetite Loss
categories
measurements
group Id
OG000
spread
20.2
value
9.8
group Id
OG001
spread
19.0
value
9.5
denoms
counts
group Id
OG000
value
624
group Id
OG001
value
645
units
Participants
title
Baseline: Constipation
categories
measurements
group Id
OG000
spread
22.4
value
1.0
group Id
OG001
spread
22.6
value
4.6
denoms
counts
group Id
OG000
value
558
group Id
OG001
value
571
units
Participants
title
Change at Cycle 5: Constipation
categories
measurements
group Id
OG000
spread
23.6
value
3.4
group Id
OG001
spread
23.1
value
7.3
denoms
counts
group Id
OG000
value
496
group Id
OG001
value
496
units
Participants
title
Change at Cycle 11: Constipation
categories
measurements
group Id
OG000
spread
23.7
value
4.1
group Id
OG001
spread
23.3
value
3.7
denoms
counts
group Id
OG000
value
410
group Id
OG001
value
462
units
Participants
title
Change at FU Month 6: Constipation
categories
measurements
group Id
OG000
spread
23.2
value
3.2
group Id
OG001
spread
24.6
value
4.3
denoms
counts
group Id
OG000
value
384
group Id
OG001
value
430
units
Participants
title
Change at FU Month 12: Constipation
categories
measurements
group Id
OG000
spread
17.6
value
8.8
group Id
OG001
spread
14.9
value
6.4
denoms
counts
group Id
OG000
value
624
group Id
OG001
value
645
units
Participants
title
Baseline: Diarrhea
categories
measurements
group Id
OG000
spread
19.3
value
-1.6
group Id
OG001
spread
19.5
value
-1.5
denoms
counts
group Id
OG000
value
558
group Id
OG001
value
571
units
Participants
title
Change at Cycle 5: Diarrhea

denoms

counts
group Id
OG000
value
743
group Id
OG001
value
743
units
Participants

description

The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), a global health status/quality of life (GHS/QoL) scale, three symptom scales (fatigue, pain, nausea, and vomiting), five single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and a perceived financial impact of the disease item. Most questions used a 4-point scale (1= Not at all to 4 = Very much; 2 questions used a 7-point scale \[1 = very poor to 7 = Excellent\]). Obtained scores are linearly transformed to a score range of 0-100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms. A positive change from baseline indicates improvement.

dispersion Type

Standard Deviation

groups

description
Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
OG000
title
Trastuzumab
description
Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
OG001
title
Trastuzumab Emtansine

param Type

MEAN

population Description

ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.

reporting Status

POSTED

time Frame

Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)

title

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)

type

SECONDARY

unit Of Measure

score on a scale

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

Preserved source evidence · Not medical advice