Trial Outcomes & Findings for Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer (NCT NCT01875367)

Last Updated: 2023-04-05

Results Overview

The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

166 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2023-04-05

Participant Flow

Eligible patients, from the randomization and before starting subcutaneous trastuzumab (SC-t), received an additional intravenous (IV-t) cycle. After receiving this cycle, patients started the treatment with the study medication, SC-t at a fixed dose of 600 mg every 3 weeks (+3 days) for 4 cycles (2 administered from the injection of a vial in a syringe and 2 with the single-use injection device \[SID\]), being randomized 1:1 in two arms of treatment without washout period.

This is not a cross-over study.

Participant milestones

Participant milestones
Measure	Arm A: T-IV + T-SC Vial + T-SC Device Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
Overall Study STARTED	81	85
Overall Study COMPLETED	76	83
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: T-IV + T-SC Vial + T-SC Device Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
Overall Study Not complete at least 2 questionaries	4	2
Overall Study Not receive study treatment	1	0

Baseline Characteristics

Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=81 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial n=85 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.	Total n=166 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	58 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	85 Participants n=7 Participants	166 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	78 Participants n=5 Participants	83 Participants n=7 Participants	161 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Arabian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Menopausal status Premenopausal	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Menopausal status Postmenopausal	73 Participants n=5 Participants	73 Participants n=7 Participants	146 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status ECOG 0	63 Participants n=5 Participants	61 Participants n=7 Participants	124 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status ECOG 1	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status ECOG 2	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Estrogen Receptor Positive	46 Participants n=5 Participants	60 Participants n=7 Participants	106 Participants n=5 Participants
Estrogen Receptor Negative	35 Participants n=5 Participants	25 Participants n=7 Participants	60 Participants n=5 Participants
Progesterone Receptor Negative	50 Participants n=5 Participants	38 Participants n=7 Participants	88 Participants n=5 Participants
Progesterone Receptor Positive	31 Participants n=5 Participants	47 Participants n=7 Participants	78 Participants n=5 Participants
Time with IV trastuzumab for metastasis at registration	1.9 years n=5 Participants	1.78 years n=7 Participants	1.8 years n=5 Participants
Treatment/s combined with IV-trastuzumab at registration Homonotherapy (HT)	34 Participants n=5 Participants	36 Participants n=7 Participants	70 Participants n=5 Participants
Treatment/s combined with IV-trastuzumab at registration Chemotherapy (CT)	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Treatment/s combined with IV-trastuzumab at registration Other anti-cancer therapy	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Treatment/s combined with IV-trastuzumab at registration Other anti-cancer therapy+CT	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Treatment/s combined with IV-trastuzumab at registration Other anti-cancer therapy+HT	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Treatment/s combined with IV-trastuzumab at registration None	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Other anti Human Epidermal growth factor Receptor 2 (HER-2) therapy at registration Pertuzumab	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Other anti Human Epidermal growth factor Receptor 2 (HER-2) therapy at registration Lapatinib	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Other anti Human Epidermal growth factor Receptor 2 (HER-2) therapy at registration None	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Administration route at registration Intravenous	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Administration route at registration Intramuscular	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Administration route at registration Subcutaneous	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Administration route at registration Oral	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Administration route at registration None	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Metastases 1 at diagnosis No	53 Participants n=5 Participants	52 Participants n=7 Participants	105 Participants n=5 Participants
Metastases 1 at diagnosis Yes	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Visceral metastases at registration Yes	41 Participants n=5 Participants	49 Participants n=7 Participants	90 Participants n=5 Participants
Visceral metastases at registration No	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Bone metastases at registration Yes	34 Participants n=5 Participants	41 Participants n=7 Participants	75 Participants n=5 Participants
Bone metastases at registration No	47 Participants n=5 Participants	44 Participants n=7 Participants	91 Participants n=5 Participants
Skin/soft tissue/lymph nodes metastases at registration Yes	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Skin/soft tissue/lymph nodes metastases at registration No	50 Participants n=5 Participants	56 Participants n=7 Participants	106 Participants n=5 Participants
Median of prior treatment lines at registration	1 Treatment lines n=5 Participants	1 Treatment lines n=7 Participants	1 Treatment lines n=5 Participants
Prior treatment lines at registration 1 Line	48 participants n=5 Participants	55 participants n=7 Participants	103 participants n=5 Participants
Prior treatment lines at registration 2 Lines	19 participants n=5 Participants	10 participants n=7 Participants	29 participants n=5 Participants
Prior treatment lines at registration 3 Lines	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Prior treatment lines at registration 4 Lines	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Prior treatment lines at registration 5 Lines	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Prior treatment lines at registration 6 Lines	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Prior treatment lines at registration 7 Lines	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Prior treatment lines at registration None Line	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Outcome measures

Outcome measures
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=76 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial n=83 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.	Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID) Patients from both arms (A and B) who received Single injection device
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference Subcutaneous	66 Participants	71 Participants	—
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference Intravenous	6 Participants	5 Participants	—
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference No preference	4 Participants	7 Participants	—

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Patients were randomized 1:1 in 2 arms: Arm A: (1 cycle IV-t followed by 2 cycles SC-t with vial followed by 2 cycles SC-t with SID) Arm B: (1 cycle IV-t followed by 2 cycles SC-t with SID followed by 2 cycles SC-t with vial) It has been analysed in patients from Intention To Treat (ITT) population which have completed questionnaire nº 3 (Arm A 72 patients and Arm B 80 patients).

The percentage of patients who indicate a preference for the use of SC administration by vial or device was analyzed. This was discussed in the answer to questionaire C3, question number 28 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of the questionnaire of experiences and preferences of the patient.

Outcome measures

Outcome measures
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=72 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial n=80 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.	Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID) Patients from both arms (A and B) who received Single injection device
Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference Device	46 Participants	44 Participants	—
Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference Vial	20 Participants	20 Participants	—
Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference No preference	4 Participants	13 Participants	—
Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference Not answered	2 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Questionnaires were given to the health care professionals of both arms. Information has been analyzed per administration type, not per arm. 39 health care professional satisfaction questionnaires were completed. Health care professionals were not considered enrolled, but did contribute to this assessment.

The medical staff satisfaction was analyzed with the answers to question number 33a (Considering all aspects, with what method of administration were you more satisfied? Between Intravenous vs. Subcutaneous: Intravenous; Subcutaneous; No differences) of the questionnaire of experiences and preferences of the medical staff. Health care professionals were not considered enrolled, but did contribute to this assessment.

Outcome measures

Outcome measures
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=39 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.	Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID) Patients from both arms (A and B) who received Single injection device
Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference Subcutaneous	34 Participants	—	—
Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference Intravenous	0 Participants	—	—
Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference No differences	4 Participants	—	—
Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference Not answered	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to 12 weeks

The medical staff satisfaction was analyzed with the answers to question number 33b (Considering all aspects, with what method of administration were you more satisfied? Between Vial vs. Device: Preferred device; Preferred vial; No Preference) of the questionnaire of experiences and preferences of the medical staff. Health care professionals were not considered enrolled, but did contribute to this assessment.

Outcome measures

Outcome measures
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=39 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.	Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID) Patients from both arms (A and B) who received Single injection device
Percentage of Medical Staff Subcutaneous Device vs. Vial Preference Preferred device	20 Participants	—	—
Percentage of Medical Staff Subcutaneous Device vs. Vial Preference Preferred vial	11 Participants	—	—
Percentage of Medical Staff Subcutaneous Device vs. Vial Preference No Preference	8 Participants	—	—

SECONDARY outcome

Timeframe: An average of 4 months

Population: This analysis was considered from 87 patients of the 166 patients included into the study, on who information of observed tasks were collected. 217 observations were made from these patients: 74 about IV-t administration process, 75 about SC-SID administration process, 68 about SC-Vial administration process.

Time spent by patient in the healthcare unit: Time between entrance and exit from the healthcare unit. Time spent by patient sitting in the infusion/treatment chair/bed: Time between sitting and rising from the patient treatment chair/bed The data was collected by qualified observers from site staff that measured the time spent by healthcare professional using a chronometer, and write it down in the paper questionnaires or directly or after in the electronic case report form.

Outcome measures

Outcome measures
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=74 Observations Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial n=75 Observations Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.	Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID) n=68 Observations Patients from both arms (A and B) who received Single injection device
Patient Time in Healthcare Unit and Sitting in Chair/Bed Healthcare unit	203 minutes Standard Deviation 123.57	144.84 minutes Standard Deviation 121.99	122.9 minutes Standard Deviation 112.33
Patient Time in Healthcare Unit and Sitting in Chair/Bed Sitting in the infusion/treatment chair/bed	100.01 minutes Standard Deviation 56.34	31.6 minutes Standard Deviation 28.74	24.75 minutes Standard Deviation 15.42

SECONDARY outcome

Timeframe: Through study treatment, an average of 12 weeks

Population: Safety Population included all patients randomized in the study who received at least one dose of treatment, and they were analyzed according to the actual treatment received (81 patients in arm A and 85 patients in arm B).

Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03.

Outcome measures

Outcome measures
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=81 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial n=85 Participants Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.	Boths Arms: Subcutaneous-Trastuzumab Device (SC-t SID) Patients from both arms (A and B) who received Single injection device
The Number of Participants Who Experienced Adverse Events (AE)	76 Participants	84 Participants	—

Adverse Events

Arm A: T-IV + T-SC Vial + T-SC Device

Serious events: 2 serious events

Other events: 76 other events

Deaths: 0 deaths

Arm B: T-IV + T-SC Device + T-SC Vial

Serious events: 10 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=81 participants at risk Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial n=85 participants at risk Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
General disorders Fever	1.2% 1/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	0.00% 0/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Cardiac disorders Heart failure	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Renal and urinary disorders Hematuria	1.2% 1/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	0.00% 0/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Reproductive system and breast disorders Nodule in left breast	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Infections and infestations Cold	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Reproductive system and breast disorders Nodule in right breast	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Musculoskeletal and connective tissue disorders Lack of strength in left leg	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Infections and infestations Catheter related infection (Bacteriemia)	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Nervous system disorders Stroke	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Reproductive system and breast disorders Surgery for surgical castration	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Musculoskeletal and connective tissue disorders Ostenecrosis produced by biphosphonates	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.

Other adverse events

Additional Information

Scientific Director / Medical Lead / Project Manager

Spanish Breast Cancer Research Group

Phone: +34916592870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm A: T-IV + T-SC Vial + T-SC Device n=81 participants at risk Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.	Arm B: T-IV + T-SC Device + T-SC Vial n=85 participants at risk Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
Investigations Platelet count decreased	1.2% 1/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	9.4% 8/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Investigations Creatinine increased	16.0% 13/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	20.0% 17/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Investigations Alanine aminotransferase increased	19.8% 16/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	11.8% 10/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Investigations Aspartate aminotransferase increased	18.5% 15/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	20.0% 17/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
General disorders Fatigue	12.3% 10/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	18.8% 16/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Cardiac disorders Heart failure	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Reproductive system and breast disorders Nodule in left breast	0.00% 0/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	1.2% 1/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Investigations Alkaline phosphatase increased	14.8% 12/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	17.6% 15/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Gastrointestinal disorders Diarrhea	7.4% 6/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	5.9% 5/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Investigations Hemoglobin increased	1.2% 1/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	0.00% 0/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Investigations Neutrophil count decreased	2.5% 2/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	0.00% 0/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Gastrointestinal disorders Nausea	4.9% 4/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	7.1% 6/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.2% 1/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	0.00% 0/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Gastrointestinal disorders Vomiting	1.2% 1/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	0.00% 0/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Investigations White blood cells decreased	18.5% 15/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	20.0% 17/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Blood and lymphatic system disorders Anemia	33.3% 27/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	37.6% 32/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
General disorders Injection site reaction	11.1% 9/81 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.	7.1% 6/85 • Through study treatment, an average of 12 weeks AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment. AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.