Trial Outcomes & Findings for A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC) (NCT NCT01926886)

NCT ID: NCT01926886

Last Updated: 2019-09-18

Results Overview

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

102 participants

Primary outcome timeframe

Up to 45 months

Results posted on

2019-09-18

Participant Flow

Participants with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (eBC) who completed the first 6 cycles of trastuzumab intravenous (IV) as part of the (neo)adjuvant treatment received 12 cycles of trastuzumab to complete a total of 18 cycles of trastuzumab were enrolled.

Participant milestones

Participant milestones
Measure	Trastuzumab Participants received trastuzumab IV infusion at initial loading dose of 8 milligrams per kilogram (mg/kg) body weight (BW) for three-weekly (q3w) regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by subcutaneous (SC) administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).	Health Care Professionals HCPs included for polling purposes. HCPs were not enrolled in the study.
Overall Study STARTED	102	21
Overall Study Received at Least 1 Dose of Study Drug	101	0
Overall Study COMPLETED	70	21
Overall Study NOT COMPLETED	32	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Trastuzumab Participants received trastuzumab IV infusion at initial loading dose of 8 milligrams per kilogram (mg/kg) body weight (BW) for three-weekly (q3w) regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by subcutaneous (SC) administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).	Health Care Professionals HCPs included for polling purposes. HCPs were not enrolled in the study.
Overall Study Administrative/other	1	0
Overall Study Adverse event/intercurrent illness	4	0
Overall Study Disease progression/recurrence	4	0
Overall Study Withdrawal by Subject	15	0
Overall Study Failure to return	3	0
Overall Study Recurrence of disease	1	0
Overall Study Progression of disease	2	0
Overall Study Death	1	0
Overall Study Did not cooperate	1	0

Baseline Characteristics

A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trastuzumab n=102 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Age, Continuous	54.38 Years STANDARD_DEVIATION 12.28 • n=93 Participants
Sex: Female, Male Female	101 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	98 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 45 months

Population: Safety Population included all enrolled participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Trastuzumab n=101 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Emergent SAEs	7.9 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Emergent AEs	90.1 percentage of participants

SECONDARY outcome

Timeframe: Prior (0 hour) to first trastuzumab SC administration at Cycle 13 (cycle length =21 days)

Population: ITT population. Here, "number of participants analysed" included participants who were evaluable for the outcome measure.

PSQ1 is a quality of care questionnaire containing 14 questions each of Sections A and B, with a total of 28 questions categorized on the opinion of participants about the clinicians, opinion of participants about the other staff and other questions. Responses to questions with section A (except question 11) were categorized to "not at all", "to a small extent", "to a moderate extent", "to a large extent", "to a very large extent", "Not applicable" and "missing". Responses to questions with section B were categorized to "Not important", "a little important", "important", "very important", "of utmost importance", "not applicable" and "missing". Responses to question 11 with section A were categorized to "Yes, but not long", "yes, quite long", "yes, much long" and "missing". Participant experience with the treatment provided during the in-hospital part of the study was evaluated with PSQ1 questionnaire completed by the participant prior to the first dose of trastuzumab SC at home.

Outcome measures

Outcome measures
Measure	Trastuzumab n=86 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1a:Clinician Communication-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1a:Clinician Communication-To a small extent	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1a:Clinician Communication-To a moderate extent	8 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1a:Clinician Communication-To a large extent	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1a:Clinician Communication-To a very large extent	49 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1b:Importance-Not important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1b:Importance-Of utmost importance	21 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1b:Importance-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2a:Confidence in clinicians-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2a:Confidence in clinicians-To a moderate extent	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2a:Confidence in clinicians-To a large extent	23 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2a:Confidence in clinicians-To a very large extent	56 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2a:Confidence in clinicians-Not Applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2a:Confidence in clinicians-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2b:Importance-A little important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2b:Importance-Very important	44 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3a:Clinicians cared about you-Not at all	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3a:Clinicians cared about you-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3a:Clinicians cared about you-To a moderate extent	6 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3a:Clinicians cared about you-To very large extent	51 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3b:Importance-Very important	47 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4a:Clinicians interested-To a small extent)	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4a:Clinicians interested-To a large extent	29 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4a:Clinicians interested-Not applicable	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4a:Clinicians interested-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4b:Importance-Important	15 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4b:Importance-Of utmost importance	15 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5a:Time with clinicians-To small extent	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5a:Time with clinicians-To a moderate extent	12 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5a:Time with clinicians-To a large extent	26 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5a:Time with clinician-To a very large extent	39 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5a:Time with clinicians-Not applicable	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5a:Time with clinicians-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5b:Importance-A little important	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5b:Importance-Important	21 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5b:Importance-Very important	45 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5b:Importance-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6a:Nurses communication-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6a:Nurses communication-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6a:Nurses communication-To a large extent	19 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6a:Nurses communication-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6b:Importance-Not important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6b:Importance-A little important	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6b:Importance-Very important	44 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6b:Importance-Of utmost importance	16 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7a:Confidence in nurses-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7a:Confidence in nurses-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7a:Confidence in nurses-To a moderate extent	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7a:Confidence in nurses-To a large extent	19 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7b:Importance-A little important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7b:Importance-Important	17 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8a:Nurses cared about you-To a small extent	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8a:Nurses cared about you-To a very large extent	52 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8a:Nurses cared about you-Not Applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8a:Nurses cared about you-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8b:Importance-A little important	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8b:Importance-Important	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8b:Importance-Of utmost importance	17 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9a:Nurses interested-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9a:Nurses interested-To a small extent	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9a:Nurses interested-To a moderate extent	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9a:Nurses interested-To a large extent	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9a:Nurses interested-To a very large extent	56 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9a:Nurses interested-Not Applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9a:Nurses interested-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9b:Importance-A little important	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9b:Importance-Important	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9b:Importance-Very important	41 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9b:Importance-Of utmost importance	14 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 9b:Importance-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10a:Time with nurses-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10a:Time with nurses-To a moderate extent	10 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10a:Time with nurses-To a large extent	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10a:Time with nurses-To a very large extent	49 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10a:Time with nurses-Not Applicable	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10a:Time with nurses-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10b:Importance-A little important	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10b:Importance-Very important	40 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10b:Importance-Missing	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11aWaited for hospital admission-Yes, but not long	34 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11a:Waited for hospital admission-Yes, quite long	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11a:Waited for hospital admission-Yes, much long	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11b:Importance-Not important	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11b:Importance-A little important	12 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11b:Importance-Important	28 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11b:Importance-Missing	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12a:Clinic equipment good order-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12a:Clinic equipment good order-To moderate extent	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12a:Clinic equipment good order-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12b:Importance-A little important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12b:Importance-Important	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12b:Importance-Very important	41 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12b:Importance-Of utmost importance	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13a:Clinic otherwise good order-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13a:Clinic otherwise good order-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13aClinic otherwise good order- Very large extent	45 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13a:Clinic otherwise good order-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13b:Importance-Very important	39 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13b:Importance-Of utmost importance	18 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13b:Importance-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14a:Satisfactory treatment-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14a:Satisfactory treatment-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14a:Satisfactory treatment-To a moderate extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14a:Satisfactory treatment-To a large extent	18 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14a:Satisfactory treatment-Not Applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14a:Satisfactory treatment-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14b:Importance-Important	12 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2b:Importance-Of utmost importance	25 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1a:Clinician Communication-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1a:Clinician Communication-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1b:Importance-A little important	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1b:Importance-Important	19 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4a:Clinicians interested-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4a:Clinicians interested-To a moderate extent	12 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4a:Clinicians interested-To a very large extent	40 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4b:Importance-A little important	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 4b:Importance-Very important	51 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5a:Time with clinicians-Not at all	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5b:Importance-Of utmost importance	14 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 5b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6a:Nurses communication-To a moderate extent	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6a:Nurses communication-To a very large extent	60 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6a:Nurses communication-Not Applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 1b:Importance-Very important	40 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2a:Confidence in clinicians-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 2b:Importance-Important	13 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3a:Clinicians cared about you-To a large extent	24 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3a:Clinicians cared about you-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3a:Clinicians cared about you-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3b:Importance-A little important	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3b:Importance-Important	16 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 3b:Importance-Of utmost importance	18 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7a:Confidence in nurses-To a very large extent	61 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7a:Confidence in nurses-Not Applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7a:Confidence in nurses-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7b:Importance-Very important	46 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7b:Importance-Of utmost importance	19 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 7b:Importance-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8a:Nurses cared about you-Not at all	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8a:Nurses cared about you-To a moderate extent	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8a:Nurses cared about you-To a large extent	25 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 8b:Importance-Very important	41 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10a:Time with nurses-To a small extent	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10b:Importance-Important	21 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10b:Importance-Of utmost importance	15 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 10b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11a:Waited for hospital admission-No	24 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11a:Waited for hospital admission-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11b:Importance-Very important	24 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 11b:Importance-Of utmost importance	12 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12a:Clinic equipment good order-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12a:Clinic equipment good order-To a large extent	34 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12aClinic equipment good order-To very large exten	46 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12a:Clinic equipment in good order-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 12b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13a:Clinic otherwise good order-To moderate extent	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13a:Clinic otherwise good order-To a large extent	32 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13a:Clinic otherwise good order-Not Applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13b:Importance-A little important	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13b:Importance-Important	23 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 13b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14a:Satisfactory treatment-To a very large extent	65 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14b:Importance-A little important	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14b:Importance-Very important	43 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 14b:Importance-Of utmost importance	25 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital 6b:Importance-Important	18 participants

SECONDARY outcome

Timeframe: Prior (0 hour) to fifth trastuzumab SC administration at Cycle 17 (cycle length=21 days)

Population: ITT population. Here, "number of participants analysed" included participants who were evaluable for the outcome measure.

PSQ2 is a quality of care questionnaire containing 13 questions each of Sections A and B, with a total of 26 questions categorized on the opinion of participants about the clinicians, opinion of participant about the other staff and other questions. Responses to questions with section A were categorized to "Not at all", "To a small extent", "to a moderate extent", "to a large extent", "to a very large extent", "Not applicable" and "missing". Responses to questions with section B were categorized to "Not important", "a little important", "important", "very important", "of utmost importance", "not applicable" and "missing". Participant experience with the treatment provided during the at-home part of the study was evaluated with the PSQ2 questionnaire completed by the participant prior to the fifth dose of trastuzumab SC at home.

Outcome measures

Outcome measures
Measure	Trastuzumab n=83 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1a:Clinicians communication-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1a:Clinicians communication-To a small extent	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1a:Clinicians communication-To a moderate extent	8 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1a:Clinicians communication-To a large extent	28 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1a:Clinicians communication-To a very large extent	34 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1a:Clinicians communication-Not Applicable	7 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1a:Clinicians communication-Missing	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1b:Importance-Not important	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1b:Importance-A little important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1b:Importance-Important	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1b:Importance-Missing	8 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2a:Confidence in the clinicians-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2a:Confidence in the clinicians-To moderate extent	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2a:Confidence in the clinicians-To a large extent	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3b:Importance-Of utmost importance	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3b:Importance-Missing	8 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4a:Clinicians interested-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4a:Clinicians interested-To a very large extent	36 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1b:Importance-Very important	37 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 1b:Importance-Of utmost importance	16 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11b:Importance-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Satisfaction-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Satisfaction-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Satisfaction-To a moderate extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Satisfaction-To a large extent	14 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Satisfaction-To a very large extent	67 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Satisfaction-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Satisfaction-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12a:Importance-A little important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12b:Importance-Important	18 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12b:Importance-Very important	42 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12b:Importance-Of utmost importance	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 12b:Importance-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13a:Care benefit at home-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13a:Care benefit at home-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13a:Care benefit at home-To moderate extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13a:Care benefit at home-To a large extent	18 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13a:Care benefit at home-To very large extent	63 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13a:Care benefit at home-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13a:Care benefit at home-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13b:Importance-A little important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13b:Importance-Important	19 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13b:Importance-Very important	41 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13b:Importance-Of utmost importance	21 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 13b:Importance-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2a:Confidence in the clinicians-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2a:Confidence in clinician-To very large extent	51 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2a:Confidence in the clinicians-Not applicable	5 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2a:Confidence in the clinicians-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2b:Importance-A little important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2b:Importance-Important	14 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2b:Importance-Very important	38 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2b:Importance-Of utmost importance	23 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 2b:Importance-Missing	8 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3a:Clinicians cared about you-Not at all	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3a:Clinicians cared about you-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3a:Clinicians cared about you-To a moderate extent	6 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3a:Clinicians cared about you-To a large extent	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3a:Clinician cared about you-To very large extent	42 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3a:Clinicians cared about you-Not Applicable	6 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3a:Clinicians cared about you-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3b:Importance-A little important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3b:Importance-Important	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 3b:Importance-Very important	34 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4a:Clinicians interested-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4a:Clinicians interested-To a moderate extent	9 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4a:Clinicians interested-To a large extent	27 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4a:Clinicians interested-Not applicable	6 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4a:Clinicians interested-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4b:Importance-A little important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4b:Importance-Important	19 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4b:Importance-Very important	34 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4b:Importance-Of utmost importance	21 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 4b:Importance-Missing	8 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5a:Clinicians interaction-Not at all	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5a:Clinicians interaction-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5a:Clinicians interaction-To moderate extent	11 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5a:Clinicians interaction-To a large extent	31 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5a:Clinicians interaction-To very large extent	30 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5a:Clinicians interaction-Not Applicable	6 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5a:Clinicians interaction-Missing	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5b:Importance-A little important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5b:Importance-Important	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5b:Importance-Very important	35 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5b:Importance-Of utmost importance	18 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 5b:Importance-Missing	8 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6a:Nurses communication-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6a:Nurses communication-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6a:Nurses communication-To a moderate extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6a:Nurses communication-To a large extent	17 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6a:Nurses communication-To a very large extent	62 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6a:Nurses communication-Not applicable	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6a:Nurses communication-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6b:Importance-A little important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6b:Importance-Important	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6b:Importance-Very important	39 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6b:Importance-Of utmost importance	21 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 6b:Importance-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7a:Confidence in the nurses-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7a:Confidence in the nurses-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7a:Confidence in the nurses-To a moderate extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7a:Confidence in the nurses-To a large extent	23 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7a:Confidence in the nurses-To a very large extent	58 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7a:Confidence in the nurses-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7a:Confidence in the nurses-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7b:Importance-A little important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7b:Importance-Important	17 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7b:Importance-Very important	41 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7b:Importance-Of utmost importance	23 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 7b:Importance-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8a:Nurses cared about you-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8a:Nurses cared about you-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8a:Nurses cared about you-To a moderate extent	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8a:Nurses cared about you-To a large extent	23 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8a:Nurses cared about you-To a very large extent	57 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8a:Nurses cared about you-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8a:Nurses cared about you-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8b:Importance-A little important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8b:Importance-Important	22 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8b:Importance-Very important	38 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8b:Importance-Of utmost importance	20 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 8b:Importance-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9a:Nurses interested-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9a:Nurses interested-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9a:Nurses interested-To a moderate extent	4 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9a:Nurses interested-To a large extent	29 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9a:Nurses interested-To a very large extent	49 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9a:Nurses interested-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9a:Nurses interested-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9b:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9b:Importance-A little important	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9b:Importance-Important	27 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9b:Importance-Very important	34 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9b:Importance-Of utmost importance	18 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 9b:Importance-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Nurses interaction-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Nurses interaction-To a small extent	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Nurses interaction-To a moderate extent	6 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Nurses interaction-To a large extent	26 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Nurses interaction-To a very large extent	49 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Nurses interaction-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Nurses interaction-Missing	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Importance-Not important	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10a:Importance-A little important	3 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10b:Importance-Important	27 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10b:Importance-Very important	34 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10b:Importance-Of utmost importance	17 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10b:Importance-Not applicable	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 10b:Importance-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11a:Nurses equipment good order-Not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11a:Nurses equipment good order-To a small extent	0 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11a:Nurses equipment good order-To moderate extent	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11a:Nurses equipment good order-To a large extent	27 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11a:Nurse equipment good order-To verylarge extent	51 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11a:Nurses equipment good order-Not applicable	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11a:Nurses equipment good order-Missing	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11b:Importance-Not important	1 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11b:Importance-A little important	2 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11b:Importance-Important	21 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11b:Importance-Very important	41 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11b:Importance-Of utmost importance	17 participants
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home 11b:Importance-Not applicable	0 participants

SECONDARY outcome

Timeframe: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

Population: ITT population. Here, "number of participants analysed" included participants who were evaluable for the outcome measure and "n" included participants who were evaluable for the specified category.

MDASI questionnaire is used to rate the severity of 13 core items (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness, numbness or tingling). Participants were asked to rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine." Total score was summed and ranged from 0 to 130, with lower scores indicating better outcome.

Outcome measures

Outcome measures
Measure	Trastuzumab n=101 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Distressed- SC (Home) - Cycle 16	2.01 units on a scale Standard Deviation 2.33
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Breath shortness- SC (Home) - Cycle 16	1.38 units on a scale Standard Deviation 2.05
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Remembering things- SC (Home) - Cycle 16	2.14 units on a scale Standard Deviation 2.12
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Lack of appetite- SC (Home) - Cycle 16	0.71 units on a scale Standard Deviation 1.63
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Pain- IV (Hospital) - Cycle 7	1.79 units on a scale Standard Deviation 2.51
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Fatigue- IV (Hospital) - Cycle 7	3.76 units on a scale Standard Deviation 2.69
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Nausea- IV (Hospital) - Cycle 7	0.82 units on a scale Standard Deviation 1.96
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Disturbed Sleep- IV (Hospital) - Cycle 7	3.01 units on a scale Standard Deviation 2.89
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Distressed- IV (Hospital) - Cycle 7	1.99 units on a scale Standard Deviation 2.27
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Breath shortness- IV (Hospital) - Cycle 7	1.59 units on a scale Standard Deviation 2.13
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Remembering things-IV (Hospital) - Cycle 7	1.97 units on a scale Standard Deviation 2.32
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Lack of appetite-IV (Hospital) - Cycle 7	0.85 units on a scale Standard Deviation 1.80
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Drowsy- IV (Hospital) - Cycle 7	2.25 units on a scale Standard Deviation 2.54
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Dry mouth- IV (Hospital) - Cycle 7	1.89 units on a scale Standard Deviation 2.51
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Feeling sad- IV (Hospital) - Cycle 7	1.90 units on a scale Standard Deviation 2.26
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Vomiting- IV (Hospital) - Cycle 7	0.34 units on a scale Standard Deviation 1.31
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Numbness- IV (Hospital) - Cycle 7	3.01 units on a scale Standard Deviation 3.20
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Pain- SC (Hospital) - Cycle 10	1.81 units on a scale Standard Deviation 2.14
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Fatigue- SC (Hospital) - Cycle 10	3.35 units on a scale Standard Deviation 2.45
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Nausea- SC (Hospital) - Cycle 10	0.61 units on a scale Standard Deviation 1.41
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Disturbed Sleep- SC (Hospital) - Cycle 10	2.70 units on a scale Standard Deviation 2.86
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Distressed- SC (Hospital) - Cycle 10	2.10 units on a scale Standard Deviation 2.57
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Breath shortness- SC (Hospital) - Cycle 10	1.29 units on a scale Standard Deviation 1.88
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Remembering thing- SC (Hospital) - Cycle 10	2.01 units on a scale Standard Deviation 2.21
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Lack of appetite- SC (Hospital) - Cycle 10	0.81 units on a scale Standard Deviation 1.67
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Drowsy- SC (Hospital) - Cycle 10	2.32 units on a scale Standard Deviation 2.52
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Dry mouth- SC (Hospital) - Cycle 10	1.42 units on a scale Standard Deviation 2.06
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Feeling sad- SC (Hospital) - Cycle 10	1.87 units on a scale Standard Deviation 2.38
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Vomiting- SC (Hospital) - Cycle 10	0.26 units on a scale Standard Deviation 0.81
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Numbness- SC (Hospital) - Cycle 10	2.73 units on a scale Standard Deviation 2.76
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Pain- SC (Home) - Cycle 13	1.54 units on a scale Standard Deviation 2.33
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Fatigue- SC (Home) - Cycle 13	3.42 units on a scale Standard Deviation 2.27
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Nausea- SC (Home) - Cycle 13	0.45 units on a scale Standard Deviation 1.25
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Disturbed Sleep- SC (Home) - Cycle 13	2.63 units on a scale Standard Deviation 2.50
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Distressed- SC (Home) - Cycle 13	1.81 units on a scale Standard Deviation 2.27
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Breath shortness- SC (Home) - Cycle 13	1.28 units on a scale Standard Deviation 2.06
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Remembering things- SC (Home) - Cycle 13	1.95 units on a scale Standard Deviation 2.07
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Lack of appetite- SC (Home) - Cycle 13	0.43 units on a scale Standard Deviation 1.29
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Drowsy- SC (Home) - Cycle 13	1.87 units on a scale Standard Deviation 2.26
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Dry mouth- SC (Home) - Cycle 13	1.57 units on a scale Standard Deviation 2.30
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Feeling sad- SC (Home) - Cycle 13	1.80 units on a scale Standard Deviation 2.32
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Vomiting- SC (Home) - Cycle 13	0.22 units on a scale Standard Deviation 1.16
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Numbness- SC (Home) - Cycle 13	2.51 units on a scale Standard Deviation 2.64
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Pain- SC (Home) - Cycle 16	1.49 units on a scale Standard Deviation 2.06
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Fatigue- SC (Home) - Cycle 16	2.79 units on a scale Standard Deviation 2.05
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Nausea- SC (Home) - Cycle 16	0.57 units on a scale Standard Deviation 1.35
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Disturbed Sleep- SC (Home) - Cycle 16	2.11 units on a scale Standard Deviation 2.28
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Drowsy- SC (Home) - Cycle 16	1.74 units on a scale Standard Deviation 2.01
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Dry mouth- SC (Home) - Cycle 16	1.39 units on a scale Standard Deviation 1.93
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Feeling sad- SC (Home) - Cycle 16	1.98 units on a scale Standard Deviation 2.24
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Vomiting- SC (Home) - Cycle 16	0.14 units on a scale Standard Deviation 0.61
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire Numbness- SC (Home) - Cycle 16	2.00 units on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

MDASI questionnaire is used to rate the interference of symptoms. The measure includes 6 symptom interference items which ask how much all symptoms, interfere with domains (general activity, mood, work, relations with others, walking, and enjoyment of life). Each items were rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely"). Lower scores indicating better outcome. Total score was summed and ranged from 0 to 50, with lower scores indicating better outcome.

Outcome measures

Outcome measures
Measure	Trastuzumab n=101 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire General activity- IV (Hospital) - Cycle 7	2.77 units on a scale Standard Deviation 2.73
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Mood- IV (Hospital) - Cycle 7	2.11 units on a scale Standard Deviation 2.13
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Work- IV (Hospital) - Cycle 7	3.22 units on a scale Standard Deviation 2.86
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Relations- IV (Hospital) - Cycle 7	1.54 units on a scale Standard Deviation 2.13
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Walking- IV (Hospital) - Cycle 7	3.34 units on a scale Standard Deviation 3.06
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Enjoyment of life- IV (Hospital) - Cycle 7	2.51 units on a scale Standard Deviation 2.55
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire General activity- SC (Hospital) - Cycle 10	2.24 units on a scale Standard Deviation 2.35
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Mood- SC (Hospital) - Cycle 10	1.92 units on a scale Standard Deviation 2.28
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Work- SC (Hospital) - Cycle 10	2.63 units on a scale Standard Deviation 2.71
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Relations- SC (Hospital) - Cycle 10	1.48 units on a scale Standard Deviation 2.30
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Walking- SC (Hospital) - Cycle 10	2.38 units on a scale Standard Deviation 2.69
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Enjoyment of life- SC (Hospital) - Cycle 10	2.21 units on a scale Standard Deviation 2.67
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire General activity- SC (Home) - Cycle 13	2.27 units on a scale Standard Deviation 2.48
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Mood- SC (Home) - Cycle 13	1.81 units on a scale Standard Deviation 2.28
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Work- SC (Home) - Cycle 13	2.35 units on a scale Standard Deviation 2.26
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Relations- SC (Home) - Cycle 13	1.13 units on a scale Standard Deviation 1.93
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Walking- SC (Home) - Cycle 13	2.13 units on a scale Standard Deviation 2.79
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Enjoyment of life- SC (Home) - Cycle 13	2.06 units on a scale Standard Deviation 2.66
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire General activity- SC (Home) - Cycle 16	1.84 units on a scale Standard Deviation 2.12
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Mood- SC (Home) - Cycle 16	1.76 units on a scale Standard Deviation 2.13
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Work- SC (Home) - Cycle 16	2.00 units on a scale Standard Deviation 2.21
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Relations- SC (Home) - Cycle 16	1.02 units on a scale Standard Deviation 1.85
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Walking- SC (Home) - Cycle 16	1.67 units on a scale Standard Deviation 2.41
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire Enjoyment of life- SC (Home) - Cycle 16	1.90 units on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: Prior (0 hours) to Cycle 12 (cycle length=21 days)

Population: ITT population

PEX-Part 1 questionnaire contains 25 items to assess participant's experience on use of trastuzumab at hospital.1.Place of treatment? 2.Was it same place as for chemotherapy? 3.How long did it take to travel there? 4.How easy was travel? 5.Company required for travelling? 6.Was travelling cost a problem? 7.Considering all these,was travelling for treatment overall a problem? 8.How helpful were nursing/medical staff? 9.How pleasant was place of study? 10.How was IV treatment given? 11.If Venous Access Device(VAD),what was it? 12.Did hospital staff have difficulty inserting cannula? 13.Time for cannulation? 14.How painful was IV? 15.How much time to access port/line usually take? 16.How painful was it? 17.Time for IV sessions? 18.Anxiety level while IV treatment? 19.How would you describe IV sessions? 20.Did hospital staff have difficulty giving SC? 21.Time for SC? 22.How painful was SC? 23.Time for SC sessions? 24.Anxiety level while SC treatment? 25.How would you describe SC sessions?

Outcome measures

Outcome measures
Measure	Trastuzumab n=102 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling overall, a problem: no	69 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Cannulation painfull: very	4 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during IV treatment: fairly	20 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital SC injection painful: not at all	53 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Place of study treatment: hospital chemo dept	87 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Place of study treatment: other chemo clinic	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Place of study treatment: Doctor's office	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Place of study treatment: other	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Place of study treatment: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Same place as for your chemotherapy: yes	87 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Same place as for your chemotherapy: no	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Same place as for your chemotherapy: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travel time: <1 hour	70 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travel time: 1 to 2 hours	12 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travel time: >2 hours	5 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travel time: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling easy: not at all	9 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling easy: fairly	44 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling easy: very	34 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling easy: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Company required for travelling: always	32 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Company required for travelling: sometimes	19 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Company required for travelling: never	36 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Company required for travelling: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling cost, a problem: not at all	60 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling cost, a problem: fairly	23 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling cost, a problem: very	4 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling cost, a problem: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling overall, a problem: yes	18 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Travelling overall, a problem: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Nursing and medical staff helpful: not at all	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Nursing and medical staff helpful: fairly	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Nursing and medical staff helpful: very	72 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Nursing and medical staff helpful: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Pleasant place of treatment: not at all	3 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Pleasant place of treatment: fairly	39 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Pleasant place of treatment: very	44 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Pleasant place of treatment: missing	16 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital IV administration method: cannula/needle	34 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital IV administration method:Venous Access Device(VAD)	47 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital IV administration method: both	6 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital IV administration method: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital VAD: Hickman	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital VAD: peripherally inserted central catheters	5 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital VAD: port-a-cath	47 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital VAD: other	9 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital VAD: missing	41 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty inserting the cannula: very often	5 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty inserting the cannula: sometimes	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty inserting the cannula: never	22 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty inserting the cannula: missing	60 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for insertion of the cannula: <5 minutes	30 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for insertion of the cannula: 6-10 minutes	7 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for insertion of the cannula: 11-15 minutes	1 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for insertion of the cannula:16-20 minutes	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for insertion of the cannula: >20 minutes	2 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for insertion of the cannula: missing	62 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Cannulation painfull: not at all	20 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Cannulation painfull: fairly	18 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Cannulation painfull: missing	60 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for connection to the access port: <5 minutes	39 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for connection to access port: 6-10 minutes	8 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for connection to access port: 11-15 minutes	1 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for connection to access port: 16-20 minutes	1 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for connection to access port: >20 minutes	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for connection to access port: missing	53 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Connection painful: not at all	36 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Connection painful: fairly	14 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Connection painful: very	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Connection painful: missing	52 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for IV session: <2 hours	21 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for IV session: 2-3 hours	25 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for IV session: 3-4 hours	26 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for IV session: >4 hours	13 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for IV session: missing	17 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during IV treatment: not at all	64 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during IV treatment: very	2 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during IV treatment: missing	16 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General IV session: very unpleasant	2 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General IV session: fairly unpleasant	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General IV session: acceptable	68 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General IV session: missing	17 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty in SC injection: very often	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty in SC injection: sometimes	4 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty in SC injection: never	82 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Difficulty in SC injection: missing	16 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC injection: <5 minutes	56 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC injection: 6-10 minutes	26 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC injection: 11-15 minutes	1 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC injection: 16-20 minutes	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC injection: >20 minutes	3 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC injection: missing	16 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital SC injection painful: fairly	33 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital SC injection painful: very	1 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital SC injection painful: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC session: <2 hours	46 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC session: 2-3 hours	24 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC session: 3-4 hours	9 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC session: >4 hours	7 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Time for SC session: missing	16 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during SC treatment: not at all	63 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during SC treatment: fairly	21 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during SC treatment: very	3 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital Anxiety during SC treatment: missing	15 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General SC session: very unpleasant	0 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General SC session: fairly unpleasant	7 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General SC session: acceptable	79 participants
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital General SC session: missing	16 participants

SECONDARY outcome

Timeframe: 1 month after end of treatment (up to 10 months)

Population: ITT population

PEX - Part 2 questionnaire contains 6 items to assess the participant's experience on the use of trastuzumab SC vials at home.Participants answered the following questions: 1. Did the nursing staff ever have any difficulty giving the trastuzumab injection SC? 2. How many minutes did the injection (it) usually take? 3. How painful was this usually? 4. How long did the SC sessions usually last from arrival until departure of the nurse? 5. How anxious did having the SC treatment make you feel? 6. In general how would you describe these SC treatment sessions at home?

Outcome measures

Outcome measures
Measure	Trastuzumab n=102 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Difficulty in SC administration: very often	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Difficulty in SC administration: sometimes	5 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Difficulty in SC administration: never	77 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Difficulty in SC administration: missing	20 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration time: <5 minutes	65 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration time: 6-10 minutes	17 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration time: 11-15 minutes	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration time: 16-20 minutes	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration time: >20 minutes	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration time: missing	20 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration Painful: not at all	61 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration Painful: fairly	20 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration Painful: very	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home SC administration Painful: missing	21 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Time for SC session: <2 hours	82 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Time for SC session: 2-3 hours	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Time for SC session: 3-4 hours	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Time for SC session: >4 hours	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Time for SC session: missing	20 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Anxiety during SC treatment: not at all	71 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Anxiety during SC treatment: fairly	11 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Anxiety during SC treatment: very	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home Anxiety during SC treatment: missing	20 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home General SC session: very unpleasant	3 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home General SC session: fairly unpleasant	0 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home General SC session: acceptable	79 participants
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home General SC session: missing	20 participants

SECONDARY outcome

Timeframe: Prior (0 hours) to Cycle 12 (cycle length=21 days)

Population: Health care professionals who participated in the study and completed the HCPEX-1 questionnaire.

HCPEX-1 questionnaire is used to assess health care professional's overall satisfaction and perceived time savings with trastuzumab SC vial in the hospital. The HCPEX-1 questionnaire (19 questions) was completed by the health care professionals administering the trastuzumab IV and SC in the hospital after at least 3 participants had completed the in-hospital part of the study.

Outcome measures

Outcome measures
Measure	Trastuzumab n=21 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for SC session: 3-4 hours	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for SC session: >4 hours	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for SC session: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliability of SC hand held syringe: not at all	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Specialty: Oncologist	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Specialty: Gynecologist	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Specialty: Oncologist/ Specialist Chemo Nurse	19 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Specialty: Other	2 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Specialty: Missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personal administration of SC: always	6 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personal administration of SC: sometimes	15 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personal administration of SC: never	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personal administration of SC: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC preparation: <5 minutes	7 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC preparation: 6-10 minutes	2 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC preparation: 11-15 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC preparation: 16-20 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC preparation: >20 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC preparation: not sure	9 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC preparation: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: <3 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: <5 minutes	16 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: 6-15 minutes	3 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: 16-30 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: 31-60 minutes	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: 61-90 minutes	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: >90 minutes	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: not sure	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time required for SC administration: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for SC session: <2 hours	14 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for SC session: 2-3 hours	7 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliability of SC hand held syringe: fairly	10 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliability of SC hand held syringe: very	11 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliability of SC hand held syringe: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Easy to administer SC hand held syringe:not at all	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Easy to administer SC hand held syringe: fairly	13 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Easy to administer SC hand held syringe: very	8 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Easy to administer SC hand held syringe: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) convenient method for IV treatment- cannula	7 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) convenient method for IV treatment- VAD	14 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) convenient method for IV treatment- not sure	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) convenient method for IV treatment- missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally administer IV: always	4 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally administer IV: sometimes	15 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally administer IV: never	2 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally administer IV: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally Cannulate: always	5 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally Cannulate: sometimes	10 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally Cannulate: never	5 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Personally Cannulate: missing	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV preparation: <5 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV preparation: 6-10 minutes	2 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV preparation: 11-15 minutes	2 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV preparation: 16-20 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV preparation: >20 minutes	5 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV preparation: not sure	10 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV preparation: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for cannulation: <5 minutes	8 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for cannulation: 6-10 minutes	4 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for cannulation: 11-15 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for cannulation: 16-20 minutes	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for cannulation: >20 minutes	2 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for cannulation: not sure	5 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for cannulation: missing	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: <3 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: <5 minutes	3 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: 6-15 minutes	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: 16-30 minutes	2 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: 31-60 minutes	8 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: 61-90 minutes	5 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: >90 minutes	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: not sure	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for connection: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV session: <2 hours	5 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV session: 2-3 hours	11 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV session: 3-4 hours	4 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV session: >4 hours	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Time for IV session: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Anxiety during IV treatment: not at all	14 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Anxiety during IV treatment: fairly	6 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Anxiety during IV treatment: very	1 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Anxiety during IV treatment: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliablily of IV treatment: not at all	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliablily of IV treatment: fairly	8 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliablily of IV treatment: very	13 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Reliablily of IV treatment: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) IV administration easy: not at all	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) IV administration easy: fairly	12 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) IV administration easy: very	9 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) IV administration easy: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Quickest administration: IV	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Quickest administration: SC (handheld syringe)	21 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Quickest administration: no difference	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Quickest administration: missing	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Require less resource: IV	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Require less resource: SC (handheld syringe)	21 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Require less resource: no difference	0 Health care professionals
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) Require less resource: missing	0 Health care professionals

SECONDARY outcome

Timeframe: From start of treatment up to 45 months

Population: ITT population

DFS was defined as time from first study drug administration (i.e. Day 1 of Cycle 7) to local, regional or distant recurrence, contralateral breast cancer or death from any cause (whichever occurred first). Diagnosis of breast cancer relapse was made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence included radiology, computerized tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainly, disease relapse was to be confirmed by histological or cytological examination of a suspicious lesion, if possible.

Outcome measures

Outcome measures
Measure	Trastuzumab n=102 Participants Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Disease-Free Survival (DFS) as Assessed by Routine Clinical, Radiological and Laboratory Criteria	NA months Median and 95% CI could not be calculated due to low number of events.

Adverse Events

Trastuzumab

Serious events: 8 serious events

Other events: 44 other events

Deaths: 2 deaths

Health Care Professionals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trastuzumab n=101 participants at risk Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).	Health Care Professionals HCPs included for polling purposes. HCPs were not enrolled in the study.
Ear and labyrinth disorders Vertigo	0.99% 1/101 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population	— 0/0 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population
Infections and infestations Infected lymphocele	0.99% 1/101 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population	— 0/0 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population
Investigations Ejection fraction decreased	5.0% 5/101 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population	— 0/0 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population
Vascular disorders Lymphoedema	0.99% 1/101 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population	— 0/0 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population

Other adverse events

Other adverse events
Measure	Trastuzumab n=101 participants at risk Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).	Health Care Professionals HCPs included for polling purposes. HCPs were not enrolled in the study.
General disorders Fatigue	33.7% 34/101 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population	— 0/0 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population
General disorders Injection site erythema	13.9% 14/101 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population	— 0/0 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population
General disorders Injection site swelling	13.9% 14/101 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population	— 0/0 • Up to 45 months An emergent adverse event was defined as occurring within 35 days after last treatment administration. Safety Population

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER