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)

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ClinicalTrials.gov Identifier: NCT01772472

Recruitment Status : Active, not recruiting

First Posted : January 21, 2013

Results First Posted : October 1, 2019

Last Update Posted : May 2, 2024

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Sponsor:

Collaborators:

NSABP Foundation Inc

German Breast Group

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Breast Cancer
Interventions	Drug: trastuzumab Drug: trastuzumab emtansine
Enrollment	1487

Participant Flow

Recruitment Details
Pre-assignment Details	1486 patients were randomized in 268 centers across 28 countries.


Arm/Group Title	Trastuzumab	Trastuzumab Emtansine
Arm/Group Description	Participants received trastuzumab 6...	Participants received trastuzumab e...
Arm/Group Description	Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.	Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
Period Title: Overall Study
Started	743	743
Completed	0	0
Not Completed	743	743
Reason Not Completed
Death	56	42
Physician Decision	1	3
Other	5	5
Lost to Follow-up	12	8
Withdrawal by Subject	72	50
Ongoing	597	635

Baseline Characteristics

Arm/Group Title		Trastuzumab	Trastuzumab Emtansine	Total
Arm/Group Description		Participants received trastuzumab 6...	Participants received trastuzumab e...	Total of all reporting groups
Arm/Group Description		Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.	Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.	Total of all reporting groups
Overall Number of Baseline Participants		743	743	1486
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The intent-to-treat (ITT) population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	743 participants	743 participants	1486 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	675 90.8%	685 92.2%	1360 91.5%
	>=65 years	68 9.2%	58 7.8%	126 8.5%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	743 participants	743 participants	1486 participants
	Female	740 99.6%	741 99.7%	1481 99.7%
	Male	3 0.4%	2 0.3%	5 0.3%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	743 participants	743 participants	1486 participants
	American Indian or Alaska Native	50 6.7%	36 4.8%	86 5.8%
	Asian	64 8.6%	65 8.7%	129 8.7%
	Native Hawaiian or Other Pacific Islander	1 0.1%	0 0.0%	1 0.1%
	Black or African American	19 2.6%	21 2.8%	40 2.7%
	White	531 71.5%	551 74.2%	1082 72.8%
	More than one race	1 0.1%	1 0.1%	2 0.1%
	Unknown or Not Reported	77 10.4%	69 9.3%	146 9.8%

Outcome Measures

1.Primary Outcome


Title	Invasive Disease-free Survival (IDFS)
Description	IDFS event was defined as the first occurrence of one of the following...
Description	IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time Frame	From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months)

Outcome Measure Data

Analysis Population Description

The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.


Arm/Group Title	Trastuzumab	Trastuzumab Emtansine
Arm/Group Description:	Participants received trastuzumab 6...	Participants received trastuzumab e...
Arm/Group Description:	Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.	Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
Overall Number of Participants Analyzed	743	743
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percent Probability
	77.02 (73.78 to 80.26)	88.27 (85.81 to 90.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trastuzumab, Trastuzumab Emtansine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.50
	Confidence Interval	95% 0.39 to 0.64
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Invasive Disease-free Survival Including Second Primary Non-breast Cancer
Description	IDFS including second primary non-breast cancer was defined the same w...
Description	IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). 3-year IDFS including second primary non-breast cancer event-free rates per treatment arm in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time Frame	From baseline up to 12 years

Outcome Measure Data Not Reported

3.Secondary Outcome


Title	Disease-free Survival
Description	Disease-free survival was defined as the time between randomization an...
Description	Disease-free survival was defined as the time between randomization and the date of the first occurrence of an invasive disease-free survival event including second primary non-breast cancer event or contralateral or ipsilateral DCIS. 3-year DFS event-free rates per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time Frame	From baseline up to 12 years

Outcome Measure Data Not Reported

4.Secondary Outcome


Title	Overall Survival (OS)
Description	Overall survival in the overall study population was defined as the ti...
Description	Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. 5 years OS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 5 years after treatment.
Time Frame	Baseline up to 12 years

Outcome Measure Data Not Reported

5.Secondary Outcome


Title	Distant Recurrence-Free Interval (DRFI)
Description	DRFI was defined as the time between randomization and the date of dis...
Description	DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3 years DRFI event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.
Time Frame	Baseline up to 12 years

Outcome Measure Data Not Reported

6.Secondary Outcome


Title	Percentage of Participants With Adverse Events
Description	An adverse event is any untoward medical occurrence in a participant a...
Description	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Time Frame	From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months)

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who have received at least one dose of study medication.


Arm/Group Title	Trastuzumab	Trastuzumab Emtansine
Arm/Group Description:	Participants received trastuzumab 6...	Participants received trastuzumab e...
Arm/Group Description:	Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.	Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
Overall Number of Participants Analyzed	720	740
Measure Type: Number Unit of Measure: Percentage of Participants
	93.3	98.8

7.Secondary Outcome


Title	Percentage of Participants With Cardiac Dysfunction
Description	Cardiac events were reported based on the NCI-CTCAE, v4.0.
Description	Cardiac events were reported based on the NCI-CTCAE, v4.0.
Time Frame	From baseline up to 12 years

Outcome Measure Data Not Reported

8.Secondary Outcome


Title	Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
Description	The EORTC QLQ-C30 included global health status, functional scales (ph...
Description	The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Time Frame	Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12

Outcome Measure Data

Analysis Population Description

Randomized Patient Population of patients with both a baseline assessment and at least one post-baseline assessment are included in the analysis.


Arm/Group Title		Trastuzumab	Trastuzumab Emtansine
Arm/Group Description:		Participants received trastuzumab 6...	Participants received trastuzumab e...
Arm/Group Description:		Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.	Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
Overall Number of Participants Analyzed		743	743
Mean (Standard Deviation) Unit of Measure: Units on a Scale
Baseline: Appetite Loss	Number Analyzed	624 participants	645 participants
Baseline: Appetite Loss		7.9 (17.4)	7.1 (16.4)
Change at Cycle 5: Appetite Loss	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Appetite Loss		1.0 (18.7)	6.5 (23.7)
Change at Cycle 11: Appetite Loss	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Appetite Loss		-0.5 (17.2)	2.9 (20.2)
Change at FU Month 6: Appetite Loss	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Appetite Loss		-1.6 (18.3)	-1.7 (19.9)
Change at FU Month 12: Appetite Loss	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Appetite Loss		0.5 (20.3)	-1.9 (20.1)
Baseline: Constipation	Number Analyzed	624 participants	645 participants
Baseline: Constipation		9.8 (20.2)	9.5 (19.0)
Change at Cycle 5: Constipation	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Constipation		1.0 (22.4)	4.6 (22.6)
Change at Cycle 11: Constipation	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Constipation		3.4 (23.6)	7.3 (23.1)
Change at FU Month 6: Constipation	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Constipation		4.1 (23.7)	3.7 (23.3)
Change at FU Month 12: Constipation	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Constipation		3.2 (23.2)	4.3 (24.6)
Baseline: Diarrhea	Number Analyzed	624 participants	645 participants
Baseline: Diarrhea		8.8 (17.6)	6.4 (14.9)
Change at Cycle 5: Diarrhea	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Diarrhea		-1.6 (19.3)	-1.5 (19.5)
Change at Cycle 11: Diarrhea	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Diarrhea		-0.4 (21.4)	-2.4 (17.5)
Change at FU Month 6: Diarrhea	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Diarrhea		-3.4 (18.5)	-1.9 (18.3)
Change at FU Month 12: Diarrhea	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Diarrhea		-2.8 (18.9)	-1.6 (18.4)
Baseline: Dyspnea	Number Analyzed	624 participants	645 participants
Baseline: Dyspnea		12.7 (20.7)	11.0 (18.8)
Change at Cycle 5: Dyspnea	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Dyspnea		2.3 (21.9)	4.1 (22.4)
Change at Cycle 11: Dyspnea	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Dyspnea		2.8 (21.2)	2.7 (20.4)
Change at FU Month 6: Dyspnea	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Dyspnea		3.3 (22.8)	3.8 (22.7)
Change at FU Month 12: Dyspnea	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Dyspnea		3.9 (24.9)	5.3 (22.4)
Baseline: Fatigue	Number Analyzed	624 participants	645 participants
Baseline: Fatigue		29.2 (21.1)	28.0 (20.0)
Change at Cycle 5: Fatigue	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Fatigue		1.1 (20.1)	5.5 (19.7)
Change at Cycle 11: Fatigue	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Fatigue		1.1 (20.5)	3.8 (21.3)
Change at FU Month 6: Fatigue	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Fatigue		-1.4 (21.9)	-0.1 (22.2)
Change at FU Month 12: Fatigue	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Fatigue		-0.1 (23.3)	-0.1 (22.1)
Baseline: Financial Difficulties	Number Analyzed	604 participants	635 participants
Baseline: Financial Difficulties		28.6 (33.3)	27.6 (31.9)
Change at Cycle 5: Financial Difficulties	Number Analyzed	530 participants	548 participants
Change at Cycle 5: Financial Difficulties		-3.1 (26.5)	-3.0 (28.0)
Change at Cycle 11: Financial Difficulties	Number Analyzed	472 participants	480 participants
Change at Cycle 11: Financial Difficulties		-5.1 (27.6)	-1.7 (28.7)
Change at FU Month 6: Financial Difficulties	Number Analyzed	393 participants	444 participants
Change at FU Month 6: Financial Difficulties		-8.4 (28.3)	-6.5 (30.6)
Change at FU Month 12: Financial Difficulties	Number Analyzed	367 participants	413 participants
Change at FU Month 12: Financial Difficulties		-10.9 (30.5)	-7.3 (31.0)
Baseline: Insomnia	Number Analyzed	624 participants	645 participants
Baseline: Insomnia		30.6 (30.8)	30.6 (29.2)
Change at Cycle 5: Insomnia	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Insomnia		1.9 (28.4)	1.3 (29.7)
Change at Cycle 11: Insomnia	Number Analyzed	494 participants	494 participants
Change at Cycle 11: Insomnia		2.4 (29.9)	1.5 (30.3)
Change at FU Month 6: Insomnia	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Insomnia		1.8 (31.3)	-0.9 (32.1)
Change at FU Month 12: Insomnia	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Insomnia		0.3 (30.4)	0.7 (31.7)
Baseline: Nausea/Vomiting	Number Analyzed	624 participants	645 participants
Baseline: Nausea/Vomiting		3.3 (9.0)	2.8 (8.0)
Change at Cycle 5: Nausea/Vomiting	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Nausea/Vomiting		1.5 (11.2)	3.2 (12.5)
Change at Cycle 11: Nausea/Vomiting	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Nausea/Vomiting		1.3 (12.8)	3.0 (11.8)
Change at FU Month 6: Nausea/Vomiting	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Nausea/Vomiting		0.8 (10.4)	0.2 (11.1)
Change at FU Month 12: Nausea/Vomiting	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Nausea/Vomiting		0.4 (10.5)	1.2 (10.9)
Baseline: Pain	Number Analyzed	624 participants	645 participants
Baseline: Pain		22.2 (22.2)	22.6 (22.8)
Change at Cycle 5: Pain	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Pain		0.0 (23.2)	1.8 (23.9)
Change at Cycle 11: Pain	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Pain		0.1 (23.1)	2.1 (24.4)
Change at FU Month 6: Pain	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Pain		-0.3 (24.6)	-0.5 (24.3)
Change at FU Month 12: Pain	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Pain		-1.2 (25.6)	-0.8 (25.4)
Baseline: Cognitive Functioning	Number Analyzed	624 participants	645 participants
Baseline: Cognitive Functioning		83.3 (20.2)	84.4 (19.0)
Change at Cycle 5: Cognitive Functioning	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Cognitive Functioning		-3.8 (18.4)	-4.5 (18.7)
Change at Cycle 11: Cognitive Functioning	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Cognitive Functioning		-5.4 (21.3)	-5.3 (19.6)
Change at FU Month 6: Cognitive Functioning	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Cognitive Functioning		-4.1 (22.0)	-6.1 (21.6)
Change at FU Month 12: Cognitive Functioning	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Cognitive Functioning		-4.9 (22.2)	-6.9 (21.7)
Baseline: Emotional Functioning	Number Analyzed	624 participants	645 participants
Baseline: Emotional Functioning		75.0 (22.0)	75.2 (21.2)
Change at Cycle 5: Emotional Functioning	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Emotional Functioning		-0.4 (20.0)	-1.3 (21.3)
Change at Cycle 11: Emotional Functioning	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Emotional Functioning		-1.0 (21.3)	0.1 (22.0)
Change at FU Month 6: Emotional Functioning	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Emotional Functioning		-2.9 (22.0)	-0.8 (23.3)
Change at FU Month 12: Emotional Functioning	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Emotional Functioning		-2.0 (22.7)	-1.6 (23.5)
Baseline: Physical Functioning	Number Analyzed	624 participants	645 participants
Baseline: Physical Functioning		84.5 (15.3)	85.8 (14.1)
Change at Cycle 5: Physical Functioning	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Physical Functioning		0.3 (12.9)	-1.6 (12.7)
Change at Cycle 11: Physical Functioning	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Physical Functioning		1.9 (14.2)	-0.6 (14.6)
Change at FU Month 6: Physical Functioning	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Physical Functioning		2.8 (15.4)	0.7 (15.1)
Change at FU Month 12: Physical Functioning	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Physical Functioning		2.7 (14.5)	0.8 (14.5)
Baseline: Role Functioning	Number Analyzed	624 participants	645 participants
Baseline: Role Functioning		77.5 (25.0)	78.6 (23.3)
Change at Cycle 5: Role Functioning	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Role Functioning		2.0 (24.3)	-0.2 (24.1)
Change at Cycle 11: Role Functioning	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Role Functioning		4.0 (24.3)	0.6 (24.5)
Change at FU Month 6: Role Functioning	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Role Functioning		7.4 (25.8)	3.6 (26.7)
Change at FU Month 12: Role Functioning	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Role Functioning		8.0 (27.5)	4.6 (25.5)
Baseline: Social Functioning	Number Analyzed	624 participants	645 participants
Baseline: Social Functioning		77.1 (24.1)	76.8 (23.2)
Change at Cycle 5: Social Functioning	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Social Functioning		4.0 (22.5)	1.6 (23.8)
Change at Cycle 11: Social Functioning	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Social Functioning		5.8 (24.0)	2.5 (23.6)
Change at FU Month 6: Social Functioning	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Social Functioning		8.5 (23.7)	6.5 (26.1)
Change at FU Month 12: Social Functioning	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Social Functioning		9.5 (25.1)	7.4 (26.4)
Baseline: Global Health Status	Number Analyzed	624 participants	645 participants
Baseline: Global Health Status		71.2 (19.3)	71.4 (18.0)
Change at Cycle 5: Global Health Status	Number Analyzed	558 participants	571 participants
Change at Cycle 5: Global Health Status		0.6 (18.9)	-1.9 (19.6)
Change at Cycle 11: Global Health Status	Number Analyzed	496 participants	496 participants
Change at Cycle 11: Global Health Status		1.7 (17.8)	-0.5 (19.9)
Change at FU Month 6: Global Health Status	Number Analyzed	410 participants	462 participants
Change at FU Month 6: Global Health Status		2.5 (19.3)	2.0 (19.2)
Change at FU Month 12: Global Health Status	Number Analyzed	384 participants	430 participants
Change at FU Month 12: Global Health Status		3.2 (19.5)	2.8 (20.1)

9.Secondary Outcome


Title	Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
Description	EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to...
Description	EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in quality of life (QOL) and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in quality of life (QOL) and negative change from baseline indicated a deterioration in QOL.
Time Frame	Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12

Outcome Measure Data

Analysis Population Description

Randomized Patient Population of patients with both a baseline assessment and at least one post-baseline assessment are included in the analysis.


Arm/Group Title		Trastuzumab	Trastuzumab Emtansine
Arm/Group Description:		Participants received trastuzumab 6...	Participants received trastuzumab e...
Arm/Group Description:		Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.	Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
Overall Number of Participants Analyzed		743	743
Mean (Standard Deviation) Unit of Measure: Units on a Scale
Baseline: Body Image	Number Analyzed	622 participants	645 participants
Baseline: Body Image		69.8 (28.5)	67.5 (28.5)
Change at Cycle 5: Body Image	Number Analyzed	555 participants	571 participants
Change at Cycle 5: Body Image		1.5 (20.5)	4.6 (22.7)
Change at Cycle 11: Body Image	Number Analyzed	493 participants	495 participants
Change at Cycle 11: Body Image		3.4 (24.4)	5.7 (23.9)
Change at FU Month 6: Body Image	Number Analyzed	409 participants	462 participants
Change at FU Month 6: Body Image		3.6 (25.1)	7.8 (25.8)
Change at FU Month 12: Body Image	Number Analyzed	383 participants	428 participants
Change at FU Month 12: Body Image		6.2 (27.1)	6.1 (27.2)
Baseline: FP	Number Analyzed	622 participants	645 participants
Baseline: FP		51.3 (31.2)	50.1 (31.7)
Change at Cycle 5: FP	Number Analyzed	555 participants	571 participants
Change at Cycle 5: FP		2.6 (28.3)	6.5 (29.9)
Change at Cycle 11: FP	Number Analyzed	493 participants	495 participants
Change at Cycle 11: FP		6.3 (30.0)	6.1 (31.4)
Change at FU Month 6: FP	Number Analyzed	409 participants	462 participants
Change at FU Month 6: FP		7.7 (33.5)	8.1 (34.6)
Change at FU Month 12: FP	Number Analyzed	383 participants	428 participants
Change at FU Month 12: FP		8.1 (31.1)	8.2 (33.0)
Baseline: Sexual Enjoyment	Number Analyzed	218 participants	241 participants
Baseline: Sexual Enjoyment		50.9 (28.8)	52.3 (28.5)
Change at Cycle 5: Sexual Enjoyment	Number Analyzed	147 participants	172 participants
Change at Cycle 5: Sexual Enjoyment		2.3 (26.4)	-1.9 (24.6)
Change at Cycle 11: Sexual Enjoyment	Number Analyzed	128 participants	137 participants
Change at Cycle 11: Sexual Enjoyment		4.4 (27.5)	4.4 (24.5)
Change at FU Month 6: Sexual Enjoyment	Number Analyzed	104 participants	126 participants
Change at FU Month 6: Sexual Enjoyment		3.2 (28.1)	0.3 (27.5)
Change at FU Month 12: Sexual Enjoyment	Number Analyzed	95 participants	114 participants
Change at FU Month 12: Sexual Enjoyment		5.6 (26.0)	1.8 (26.2)
Baseline: Sexual Function	Number Analyzed	550 participants	564 participants
Baseline: Sexual Function		20.2 (23.6)	22.0 (23.4)
Change at Cycle 5: Sexual Function	Number Analyzed	456 participants	466 participants
Change at Cycle 5: Sexual Function		3.3 (20.0)	2.3 (20.0)
Change at Cycle 11: Sexual Function	Number Analyzed	393 participants	382 participants
Change at Cycle 11: Sexual Function		3.1 (20.8)	1.9 (20.3)
Change at FU Month 6: Sexual Function	Number Analyzed	321 participants	360 participants
Change at FU Month 6: Sexual Function		5.1 (23.9)	4.3 (23.1)
Change at FU Month 12: Sexual Function	Number Analyzed	289 participants	319 participants
Change at FU Month 12: Sexual Function		5.9 (23.7)	5.2 (22.7)
Baseline: Arm Symptoms	Number Analyzed	622 participants	645 participants
Baseline: Arm Symptoms		24.6 (21.1)	24.5 (21.0)
Change at Cycle 5: Arm Symptoms	Number Analyzed	555 participants	571 participants
Change at Cycle 5: Arm Symptoms		-2.8 (20.9)	-2.6 (23.0)
Change at Cycle 11: Arm Symptoms	Number Analyzed	493 participants	495 participants
Change at Cycle 11: Arm Symptoms		-2.6 (21.2)	0.2 (24.2)
Change at FU Month 6: Arm Symptoms	Number Analyzed	409 participants	462 participants
Change at FU Month 6: Arm Symptoms		-3.0 (23.5)	-1.3 (24.2)
Change at FU Month 12: Arm Symptoms	Number Analyzed	383 participants	428 participants
Change at FU Month 12: Arm Symptoms		-5.7 (22.8)	-1.5 (22.6)
Baseline: Breast Symptoms	Number Analyzed	622 participants	645 participants
Baseline: Breast Symptoms		22.7 (19.1)	21.4 (17.9)
Change at Cycle 5: Breast Symptoms	Number Analyzed	555 participants	571 participants
Change at Cycle 5: Breast Symptoms		-1.1 (20.3)	-1.1 (19.1)
Change at Cycle 11: Breast Symptoms	Number Analyzed	493 participants	495 participants
Change at Cycle 11: Breast Symptoms		-3.7 (19.8)	-0.6 (19.5)
Change at FU Month 6: Breast Function	Number Analyzed	409 participants	462 participants
Change at FU Month 6: Breast Function		-6.5 (20.0)	-2.2 (19.7)
Change at Follow-up Month 12: Breast Function	Number Analyzed	383 participants	428 participants
Change at Follow-up Month 12: Breast Function		-8.3 (19.9)	-3.8 (19.2)
Baseline: Systemic Therapy Side Effects (SE)	Number Analyzed	622 participants	645 participants
Baseline: Systemic Therapy Side Effects (SE)		16.7 (13.7)	16.9 (14.1)
Change at Cycle 5: Systemic Therapy SE	Number Analyzed	555 participants	571 participants
Change at Cycle 5: Systemic Therapy SE		0.7 (13.0)	5.5 (15.3)
Change at Cycle 11: Systemic Therapy SE	Number Analyzed	493 participants	495 participants
Change at Cycle 11: Systemic Therapy SE		1.2 (12.2)	4.2 (15.4)
Change at FU Month 6: Systemic Therapy SE	Number Analyzed	409 participants	462 participants
Change at FU Month 6: Systemic Therapy SE		1.9 (13.9)	1.1 (15.3)
Change at FU Month 12: Systemic Therapy SE	Number Analyzed	383 participants	428 participants
Change at FU Month 12: Systemic Therapy SE		1.3 (13.9)	1.4 (16.3)
Baseline: Upset by Hair Loss Item	Number Analyzed	77 participants	96 participants
Baseline: Upset by Hair Loss Item		40.3 (35.6)	50.7 (38.4)
Change at Cycle 5: Upset by Hair Loss Item	Number Analyzed	13 participants	17 participants
Change at Cycle 5: Upset by Hair Loss Item		-5.1 (38.1)	-17.6 (39.3)
Change at Cycle 11: Upset by Hair Loss Item	Number Analyzed	14 participants	14 participants
Change at Cycle 11: Upset by Hair Loss Item		-28.6 (45.0)	-14.3 (33.9)
Change at FU Month 6: Upset by Hair Loss Item	Number Analyzed	25 participants	22 participants
Change at FU Month 6: Upset by Hair Loss Item		-12.0 (47.0)	-15.2 (42.1)
Change at FU Month 12: Upset by Hair Loss Item	Number Analyzed	23 participants	21 participants
Change at FU Month 12: Upset by Hair Loss Item		-2.9 (37.5)	-14.3 (41.6)

10.Secondary Outcome


Title	Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1)
Description	Blood and serum samples for measurement of trastuzumab emtansine, tota...
Description	Blood and serum samples for measurement of trastuzumab emtansine, total trastuzumab, and DM1 will be obtained from patients randomized to the trastuzumab emtansine arm.
Time Frame	Cycle (C) 1, Day (D) 1 and C4D1 of pre-infusion, C1D1 and C4D1 post-infusion, C2D1 and C5D1 pre-infusion and study treatment termination

Outcome Measure Data Not Reported

11.Secondary Outcome


Title	Serum Concentrations (AUC) of Trastuzumab
Description	Serum blood samples were collected for trastuzumab measurement prior t...
Description	Serum blood samples were collected for trastuzumab measurement prior to dosing and 15-30 minutes post infusion for Cycle 1 and Cycle 4. Additional serum samples were collected at study treatment termination.
Time Frame	C1D1 and C4D1 of post-infusion and study treatment termination

Outcome Measure Data Not Reported

12.Secondary Outcome


Title	Plasma Concentrations of DM1
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 1 on Cycles 1 and 4. Each cycle is 21 days.

Outcome Measure Data Not Reported

13.Secondary Outcome


Title	Trastuzumab Emtansine Exposure
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 1 on Cycles 1, 2, 4 and 5, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.

Outcome Measure Data Not Reported

14.Secondary Outcome


Title	Anti-trastuzumab Emtansine Antibody (ATA)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.

Outcome Measure Data Not Reported

15.Secondary Outcome


Title	Anti-trastuzumab Antibody (ATA)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days.

Outcome Measure Data Not Reported

Adverse Events

Time Frame	From baseline to primary clinical cutoff date of approximately 64 months
Adverse Event Reporting Description	Safety population was analyzed.

Arm/Group Title	Trastuzumab		Trastuzumab Emtansine
Arm/Group Description	Participants received trastuzumab 6...		Participants received trastuzumab e...
Arm/Group Description	Participants received trastuzumab 6 milligrams/kilogram (mg/kg) intravenously (IV) every 3 weeks for 14 cycles.		Participants received trastuzumab emtansine 3.6 mg/kg IV every 3 weeks for 14 cycles.
All-Cause Mortality
	Trastuzumab		Trastuzumab Emtansine
	Affected / at Risk (%)		Affected / at Risk (%)
Total	56/720 (7.78%)		42/740 (5.68%)
Serious Adverse Events Serious Adverse Events
	Trastuzumab		Trastuzumab Emtansine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	58/720 (8.06%)		94/740 (12.70%)
Cardiac disorders
Cardiac Failure ^† 1	2/720 (0.28%)	2	2/740 (0.27%)	2
Atrial Fibrillation ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Pericarditis ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Eye disorders
Vision Blurred ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Gastrointestinal disorders
Vomiting ^† 1	2/720 (0.28%)	3	3/740 (0.41%)	4
Abdominal Pain ^† 1	1/720 (0.14%)	2	3/740 (0.41%)	3
Diarrhoea ^† 1	1/720 (0.14%)	1	1/740 (0.14%)	1
Nausea ^† 1	1/720 (0.14%)	2	1/740 (0.14%)	1
Colitis ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Haemorrhoids ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Ileal Perforation ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Impaired gastric Emptying ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Large Intestinal Obstruction ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Pancreatitis ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
General disorders
Non-Cardiac Chest pain ^† 1	2/720 (0.28%)	2	3/740 (0.41%)	3
Influenza Like Illness ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Pyrexia ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Systemic Inflammatory Response Syndrome ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Hepatobiliary disorders
Cholecystitis ^† 1	1/720 (0.14%)	1	1/740 (0.14%)	1
Nodular Regenerative Hyperplasia ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Gallbladder Polyp ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Hepatic Cyst ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Hepatitis ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Immune system disorders
Hypersensitivity ^† 1	0/720 (0.00%)	0	4/740 (0.54%)	4
Infections and infestations
Mastitis ^† 1	6/720 (0.83%)	7	8/740 (1.08%)	8
Device Related Infection ^† 1	0/720 (0.00%)	0	6/740 (0.81%)	6
Bronchitis ^† 1	1/720 (0.14%)	1	3/740 (0.41%)	3
Pneumonia ^† 1	1/720 (0.14%)	1	3/740 (0.41%)	3
Skin Infection ^† 1	2/720 (0.28%)	2	2/740 (0.27%)	2
Lung Infection ^† 1	1/720 (0.14%)	1	2/740 (0.27%)	2
Urinary Tract Infection ^† 1	2/720 (0.28%)	2	1/740 (0.14%)	1
Wound Infection ^† 1	2/720 (0.28%)	2	1/740 (0.14%)	1
Appendicitis ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Cellulitis ^† 1	1/720 (0.14%)	1	1/740 (0.14%)	1
Gastroenteritis ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Abscess Intestinal ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Cystitis ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Diverticulitis ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Enterocolitis Infections ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Implant Site Cellulitis ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Infected Seroma ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Influenza ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Perirectal Abscess ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Staphylococcal Bacteraemia ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Tonsillitis ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Vestibular Neuronitis ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Vulvitis ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Injury, poisoning and procedural complications
Wound Dehiscence ^† 1	1/720 (0.14%)	1	3/740 (0.41%)	3
Post Procedural haemorrhage ^† 1	1/720 (0.14%)	1	1/740 (0.14%)	1
Radiation Pneumonitis ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Tibia Fracture ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Ankle Fracture ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Femur Fracture ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Limb Fracture ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Seroma ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Wound Complication ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Wrist Fracture ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Investigations
Platelet Count Decreased ^† 1	0/720 (0.00%)	0	10/740 (1.35%)	10
Aspartate Aminotransferase Increased ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Ejection Fraction Decreased ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Troponin T Increased ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Metabolism and nutrition disorders
Hyperglycaemia ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back Pain ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Muscular Weakness ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Stage 1 ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Endometrial Adenocarcinoma ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Intraductal Proliferative Breast Lesion ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Pituitary Tumour Benign ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Nervous system disorders
Peripheral Sensory Neuropathy ^† 1	0/720 (0.00%)	0	3/740 (0.41%)	3
Peripheral Motor Neuropathy ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Syncope ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Dizziness ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Haemorrhage intracranial ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Neuralgia ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Paraesthesia ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Psychiatric disorders
Anxiety ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	2
Suicidal Ideation ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Renal and urinary disorders
Acute Kidney Injury ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Bladder Pain ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Reproductive system and breast disorders
Ovarian Cyst ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Menorrhagia ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Uterine Haemorrhage ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Uterine Obstruction ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Uterine Prolapse ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Epistaxis ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Pneumonitis ^† 1	0/720 (0.00%)	0	2/740 (0.27%)	2
Aspiration ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Chronic Obstructive Pulmonary ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Dyspnoea ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Pleural Effusion ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Pulmonary fibrosis ^† 1	0/720 (0.00%)	0	1/740 (0.14%)	1
Skin and subcutaneous tissue disorders
Photosensitivity reaction ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Telangiectasia ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
Vascular disorders
Embolism ^† 1	3/720 (0.42%)	3	1/740 (0.14%)	1
Hypertension ^† 1	1/720 (0.14%)	1	1/740 (0.14%)	1
Haematoma ^† 1	1/720 (0.14%)	1	0/740 (0.00%)	0
1 Term from vocabulary, MedDRA 21.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Trastuzumab		Trastuzumab Emtansine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	634/720 (88.06%)		719/740 (97.16%)
Blood and lymphatic system disorders
Anaemia ^† 1	60/720 (8.33%)	79	74/740 (10.00%)	89
Eye disorders
lacrimation Increased ^† 1	13/720 (1.81%)	13	41/740 (5.54%)	44
Gastrointestinal disorders
Nausea ^† 1	93/720 (12.92%)	111	308/740 (41.62%)	438
Constipation ^† 1	59/720 (8.19%)	66	126/740 (17.03%)	152
Diarrhoea ^† 1	89/720 (12.36%)	116	91/740 (12.30%)	117
Vomiting ^† 1	37/720 (5.14%)	45	106/740 (14.32%)	139
Dry Mouth ^† 1	9/720 (1.25%)	9	100/740 (13.51%)	109
Stomatitis ^† 1	27/720 (3.75%)	29	80/740 (10.81%)	96
Abdominal Pain ^† 1	42/720 (5.83%)	48	55/740 (7.43%)	66
General disorders
Fatigue ^† 1	243/720 (33.75%)	276	366/740 (49.46%)	456
Influenza like Illness ^† 1	86/720 (11.94%)	96	100/740 (13.51%)	138
Pain ^† 1	92/720 (12.78%)	113	93/740 (12.57%)	114
Pyrexia ^† 1	29/720 (4.03%)	32	76/740 (10.27%)	98
Oedema Peripheral ^† 1	52/720 (7.22%)	56	29/740 (3.92%)	33
Chills ^† 1	14/720 (1.94%)	16	39/740 (5.27%)	57
Infections and infestations
Upper Respiratory Tract Infection ^† 1	53/720 (7.36%)	65	58/740 (7.84%)	69
Urinary Tract Infection ^† 1	37/720 (5.14%)	39	64/740 (8.65%)	79
Injury, poisoning and procedural complications
Radiation Skin Injury ^† 1	199/720 (27.64%)	208	188/740 (25.41%)	198
Investigations
Aspartate Aminotransferase Increased ^† 1	40/720 (5.56%)	44	209/740 (28.24%)	253
Platelet Count Decreased ^† 1	17/720 (2.36%)	21	205/740 (27.70%)	256
Alanine Aminotransferase Increased ^† 1	41/720 (5.69%)	51	171/740 (23.11%)	208
White Blood Cell Count Decreased ^† 1	42/720 (5.83%)	62	61/740 (8.24%)	81
Neutrophil Count Decreased ^† 1	36/720 (5.00%)	46	61/740 (8.24%)	78
Blood Alkaline Phosphatase Increased ^† 1	13/720 (1.81%)	14	61/740 (8.24%)	68
Blood Bilirubin Increased ^† 1	2/720 (0.28%)	2	49/740 (6.62%)	74
Metabolism and nutrition disorders
Decreased Appetite ^† 1	16/720 (2.22%)	19	62/740 (8.38%)	70
Hypokalaemia ^† 1	14/720 (1.94%)	20	48/740 (6.49%)	58
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	148/720 (20.56%)	162	192/740 (25.95%)	221
Myalgia ^† 1	80/720 (11.11%)	87	114/740 (15.41%)	125
Pain In Extremity ^† 1	70/720 (9.72%)	81	86/740 (11.62%)	97
Back Pain ^† 1	66/720 (9.17%)	73	53/740 (7.16%)	56
Bone Pain ^† 1	35/720 (4.86%)	38	52/740 (7.03%)	55
Muscle Spasms ^† 1	45/720 (6.25%)	45	33/740 (4.46%)	36
Nervous system disorders
Headache ^† 1	122/720 (16.94%)	146	210/740 (28.38%)	287
Peripheral Sensory Neuropathy ^† 1	50/720 (6.94%)	51	135/740 (18.24%)	146
Dizziness ^† 1	57/720 (7.92%)	61	69/740 (9.32%)	76
Paraesthesia ^† 1	40/720 (5.56%)	43	60/740 (8.11%)	72
Dysgeusia ^† 1	11/720 (1.53%)	12	60/740 (8.11%)	61
Psychiatric disorders
Insomnia ^† 1	86/720 (11.94%)	95	101/740 (13.65%)	110
Depression ^† 1	44/720 (6.11%)	47	41/740 (5.54%)	44
Anxiety ^† 1	42/720 (5.83%)	44	27/740 (3.65%)	29
Reproductive system and breast disorders
Breast pain ^† 1	42/720 (5.83%)	50	53/740 (7.16%)	56
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	86/720 (11.94%)	93	100/740 (13.51%)	112
Epistaxis ^† 1	25/720 (3.47%)	30	158/740 (21.35%)	220
Dyspnoea ^† 1	52/720 (7.22%)	56	62/740 (8.38%)	69
Oropharyngeal Pain ^† 1	33/720 (4.58%)	36	37/740 (5.00%)	39
Skin and subcutaneous tissue disorders
Pruritus ^† 1	42/720 (5.83%)	44	51/740 (6.89%)	57
Dry Skin ^† 1	36/720 (5.00%)	41	48/740 (6.49%)	52
Rash Maculo-Papular ^† 1	26/720 (3.61%)	27	42/740 (5.68%)	49
Dermatitis Acneiform ^† 1	21/720 (2.92%)	23	39/740 (5.27%)	44
Vascular disorders
Hot Flush ^† 1	146/720 (20.28%)	154	95/740 (12.84%)	99
Lymphoedema ^† 1	48/720 (6.67%)	51	37/740 (5.00%)	37
Hypertension ^† 1	34/720 (4.72%)	38	41/740 (5.54%)	58
1 Term from vocabulary, MedDRA 21.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Communications
Organization:	Hoffmann-La Roche
Phone:	800 821-8590
EMail:	genentech@druginfo.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.

Layout table for additonal information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01772472
Other Study ID Numbers:	BO27938 2012-002018-37 ( EudraCT Number )
First Submitted:	January 17, 2013
First Posted:	January 21, 2013
Results First Submitted:	July 24, 2019
Results First Posted:	October 1, 2019
Last Update Posted:	May 2, 2024

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