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Trial record 14 of 30 for:    Guatemala | Dominican Republic

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (SafeHER)

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ClinicalTrials.gov Identifier: NCT01566721
Recruitment Status : Active, not recruiting
First Posted : March 29, 2012
Results First Posted : April 18, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasms
Intervention Drug: Herceptin
Enrollment 2577

Recruitment Details  
Pre-assignment Details Of the 2984 participants screened, a total of 2577 participants were enrolled into the trial, and 2573 participants received at least one dose of study treatment.
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by Single-Use Injection Device (SID)
Hide Arm/Group Description Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe. Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Period Title: Overall Study
Started 1867 710
Received Treatment 1864 709
Completed 0 0
Not Completed 1867 710
Reason Not Completed
Ongoing Study             1649             659
Withdrawal by Subject             58             15
Disease Progression/Recurrence             123             28
Lost to Follow-up             18             0
Death             6             3
Not Specified             10             4
Withdrew Prior to Treatment             3             1
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID Total
Hide Arm/Group Description Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe. Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP. Total of all reporting groups
Overall Number of Baseline Participants 1867 710 2577
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Population: All participants enrolled into the study regardless of whether treatment was received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1867 participants 710 participants 2577 participants
54.0  (12.01) 53.0  (11.32) 53.7  (11.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1867 participants 710 participants 2577 participants
Female
1863
  99.8%
710
 100.0%
2573
  99.8%
Male
4
   0.2%
0
   0.0%
4
   0.2%
1.Primary Outcome
Title Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Hide Description Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.
Time Frame From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Overall Number of Participants Analyzed 1864 709
Measure Type: Number
Unit of Measure: percentage of participants
88.6 89.0
2.Primary Outcome
Title Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
Hide Description Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
Time Frame From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Overall Number of Participants Analyzed 1864 709
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.0
(22.1 to 26.0)
21.0
(18.1 to 24.2)
3.Primary Outcome
Title Percentage of Participants With Treatment Interruption Due to an AE
Hide Description Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.
Time Frame From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Overall Number of Participants Analyzed 1864 709
Measure Type: Number
Unit of Measure: percentage of participants
9.8 10.4
4.Primary Outcome
Title Number of Herceptin Cycles Received
Hide Description Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
Time Frame From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID Cohort B: SC Herceptin by SID (Self-Administered)
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
Overall Number of Participants Analyzed 1864 709 550
Median (Full Range)
Unit of Measure: cycles
18.0
(1 to 19)
18.0
(1 to 18)
16.0
(1 to 17)
5.Primary Outcome
Title Percentage of Participants by Total Number of Herceptin Cycles Received
Hide Description Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.
Time Frame From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID Cohort B: SC Herceptin by SID (Self- Administered)
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
Overall Number of Participants Analyzed 1864 709 550
Measure Type: Number
Unit of Measure: percentage of participants
1 Cycle Received 1.0 0.8 2.7
2 Cycles Received 0.5 0.4 1.3
3 Cycles Received 0.5 0.1 1.1
4 Cycles Received 1.2 0.7 1.6
5 Cycles Received 0.8 0.6 1.3
6 Cycles Received 0.5 0.1 1.6
7 Cycles Received 0.7 0.8 2.2
8 Cycles Received 0.9 0.3 2.2
9 Cycles Received 0.2 0.6 1.8
10 Cycles Received 0.3 0.1 1.5
11 Cycles Received 0.4 0.3 3.5
12 Cycles Received 0.9 0.8 2.5
13 Cycles Received 0.2 0 4.9
14 Cycles Received 0.5 0.6 6.9
15 Cycles Received 0.5 0.4 10.7
16 Cycles Received 0.6 0.3 21.6
17 Cycles Received 1.0 1.1 32.5
18 Cycles Received 89.2 91.8 0
19 Cycles Received 0.2 0 0
6.Primary Outcome
Title Percentage of Participants Who Received Concomitant Cancer Therapy
Hide Description Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.
Time Frame From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Overall Number of Participants Analyzed 1864 709
Measure Type: Number
Unit of Measure: percentage of participants
Chemotherapy 58.2 63.9
Radiotherapy 51.3 48.5
Hormone Therapy 53.5 50.4
7.Primary Outcome
Title Percentage of Participants Who Received Concomitant Non-Cancer Therapy
Hide Description Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.
Time Frame From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Overall Number of Participants Analyzed 1864 709
Measure Type: Number
Unit of Measure: percentage of participants
89.1 89.7
8.Secondary Outcome
Title Disease-Free Survival (DFS)
Hide Description DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.
Time Frame From Baseline to time of event (up to approximately 8 years)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Participants Who Died by Data Cutoff of 10 March 2015
Hide Description The percentage of participants who died from any cause was reported.
Time Frame From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Hide Arm/Group Description:
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
Overall Number of Participants Analyzed 1867 710
Measure Type: Number
Unit of Measure: percentage of participants
1.5 0.8
10.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame From Baseline to time of event (up to approximately 8 years)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Hide Description The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.
Time Frame Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.
Arm/Group Title Cohort B: SC Herceptin by SID (Self- Administered)
Hide Arm/Group Description:
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
Overall Number of Participants Analyzed 550
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 4: Comfortable, Strongly Disagree (n=514) 4.7
Cycle 4: Comfortable, Disagree (n=514) 2.3
Cycle 4: Comfortable, Unsure (n=514) 7.6
Cycle 4: Comfortable, Agree (n=514) 41.6
Cycle 4: Comfortable, Strongly Agree (n=514) 43.6
Cycle 4: Comfortable, Response Missing (n=514) 0.2
Cycle 4: Easy to Use, Strongly Disagree (n=514) 3.7
Cycle 4: Easy to Use, Disagree (n=514) 0.6
Cycle 4: Easy to Use, Unsure (n=514) 1.8
Cycle 4: Easy to Use, Agree (n=514) 37.7
Cycle 4: Easy to Use, Strongly Agree (n=514) 56.0
Cycle 4: Easy to Use, Response Missing (n=514) 0.2
Cycle 4: Confident, Strongly Disagree (n=514) 3.9
Cycle 4: Confident, Disagree (n=514) 0.8
Cycle 4: Confident, Unsure (n=514) 7.2
Cycle 4: Confident, Agree (n=514) 42.8
Cycle 4: Confident, Strongly Agree (n=514) 45.1
Cycle 4: Confident, Response Missing (n=514) 0.2
Cycle 4: Satisfactory, Strongly Disagree (n=514) 3.9
Cycle 4: Satisfactory, Disagree (n=514) 0.6
Cycle 4: Satisfactory, Unsure (n=514) 2.7
Cycle 4: Satisfactory, Agree (n=514) 38.7
Cycle 4: Satisfactory, Strongly Agree (n=514) 53.9
Cycle 4: Satisfactory, Response Missing (n=514) 0.2
Cycle 4: Continue, Strongly Disagree (n=514) 3.9
Cycle 4: Continue, Disagree (n=514) 1.4
Cycle 4: Continue, Unsure (n=514) 5.3
Cycle 4: Continue, Agree (n=514) 33.5
Cycle 4: Continue, Strongly Agree (n=514) 55.8
Cycle 4: Continue, Response Missing (n=514) 0.2
LSFU: Comfortable, Strongly Disagree (n=415) 3.6
LSFU: Comfortable, Disagree (n=415) 3.1
LSFU: Comfortable, Unsure (n=415) 5.3
LSFU: Comfortable, Agree (n=415) 35.9
LSFU: Comfortable, Strongly Agree (n=415) 51.8
LSFU: Comfortable, Response Missing (n=415) 0.2
LSFU: Easy to Use, Strongly Disagree (n=415) 3.9
LSFU: Easy to Use, Disagree (n=415) 1.0
LSFU: Easy to Use, Unsure (n=415) 1.7
LSFU: Easy to Use, Agree (n=415) 34.9
LSFU: Easy to Use, Strongly Agree (n=415) 58.6
LSFU: Easy to Use, Response Missing (n=415) 0
LSFU: Confident, Strongly Disagree (n=415) 4.6
LSFU: Confident, Disagree (n=415) 1.2
LSFU: Confident, Unsure (n=415) 4.3
LSFU: Confident, Agree (n=415) 33.3
LSFU: Confident, Strongly Agree (n=415) 56.6
LSFU: Confident, Response Missing (n=415) 0
LSFU: Satisfactory, Strongly Disagree (n=415) 4.3
LSFU: Satisfactory, Disagree (n=415) 1.2
LSFU: Satisfactory, Unsure (n=415) 2.2
LSFU: Satisfactory, Agree (n=415) 30.8
LSFU: Satisfactory, Strongly Agree (n=415) 61.2
LSFU: Satisfactory, Response Missing (n=415) 0.2
LSFU: Continue, Strongly Disagree (n=415) 4.6
LSFU: Continue, Disagree (n=415) 1.2
LSFU: Continue, Unsure (n=415) 2.9
LSFU: Continue, Agree (n=415) 28.2
LSFU: Continue, Strongly Agree (n=415) 63.1
LSFU: Continue, Response Missing (n=415) 0
Time Frame From Day 1 up to 19 cycles (approximately 1 year)
Adverse Event Reporting Description Safety Population
 
Arm/Group Title Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Hide Arm/Group Description Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe. Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
All-Cause Mortality
Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Affected / at Risk (%) Affected / at Risk (%)
Total   242/1864 (12.98%)   84/709 (11.85%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  39/1864 (2.09%)  14/709 (1.97%) 
Neutropenia * 1  9/1864 (0.48%)  6/709 (0.85%) 
Febrile bone marrow aplasia * 1  2/1864 (0.11%)  2/709 (0.28%) 
Anaemia * 1  3/1864 (0.16%)  0/709 (0.00%) 
Leukocytosis * 1  2/1864 (0.11%)  0/709 (0.00%) 
Leukopenia * 1  2/1864 (0.11%)  0/709 (0.00%) 
Pancytopenia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Thymus enlargement * 1  1/1864 (0.05%)  0/709 (0.00%) 
Cardiac disorders     
Cardiac failure congestive * 1  10/1864 (0.54%)  1/709 (0.14%) 
Atrial fibrillation * 1  2/1864 (0.11%)  0/709 (0.00%) 
Angina unstable * 1  2/1864 (0.11%)  0/709 (0.00%) 
Coronary artery disease * 1  2/1864 (0.11%)  0/709 (0.00%) 
Left ventricular dysfunction * 1  1/1864 (0.05%)  1/709 (0.14%) 
Myocardial ischaemia * 1  2/1864 (0.11%)  0/709 (0.00%) 
Pericarditis * 1  1/1864 (0.05%)  1/709 (0.14%) 
Supraventricular tachycardia * 1  2/1864 (0.11%)  0/709 (0.00%) 
Acute myocardial infarction * 1  1/1864 (0.05%)  0/709 (0.00%) 
Atrial thrombosis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Atrioventricular block second degree * 1  1/1864 (0.05%)  0/709 (0.00%) 
Myocarditis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Palpitations * 1  1/1864 (0.05%)  0/709 (0.00%) 
Stress cardiomyopathy * 1  1/1864 (0.05%)  0/709 (0.00%) 
Ventricular arrhythmia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  2/1864 (0.11%)  0/709 (0.00%) 
Meniere's disease * 1  1/1864 (0.05%)  0/709 (0.00%) 
Endocrine disorders     
Hypothyroidism * 1  0/1864 (0.00%)  1/709 (0.14%) 
Gastrointestinal disorders     
Diarrhoea * 1  8/1864 (0.43%)  4/709 (0.56%) 
Nausea * 1  5/1864 (0.27%)  0/709 (0.00%) 
Pancreatitis * 1  3/1864 (0.16%)  0/709 (0.00%) 
Abdominal pain upper * 1  1/1864 (0.05%)  1/709 (0.14%) 
Pancreatitis acute * 1  2/1864 (0.11%)  0/709 (0.00%) 
Vomiting * 1  2/1864 (0.11%)  0/709 (0.00%) 
Abdominal pain * 1  1/1864 (0.05%)  0/709 (0.00%) 
Abdominal discomfort * 1  1/1864 (0.05%)  0/709 (0.00%) 
Colitis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Constipation * 1  1/1864 (0.05%)  0/709 (0.00%) 
Gastritis erosive * 1  1/1864 (0.05%)  0/709 (0.00%) 
Gastrointestinal pain * 1  1/1864 (0.05%)  0/709 (0.00%) 
Intestinal polyp * 1  0/1864 (0.00%)  1/709 (0.14%) 
Neutropenic colitis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Subileus * 1  1/1864 (0.05%)  0/709 (0.00%) 
General disorders     
Pyrexia * 1  11/1864 (0.59%)  7/709 (0.99%) 
Device breakage * 1  1/1864 (0.05%)  1/709 (0.14%) 
General physical health deterioration * 1  1/1864 (0.05%)  1/709 (0.14%) 
Asthenia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Chest discomfort * 1  0/1864 (0.00%)  1/709 (0.14%) 
Chest pain * 1  1/1864 (0.05%)  0/709 (0.00%) 
Death * 1  0/1864 (0.00%)  1/709 (0.14%) 
Device defective * 1  1/1864 (0.05%)  0/709 (0.00%) 
Fatigue * 1  1/1864 (0.05%)  0/709 (0.00%) 
Influenza like illness * 1  1/1864 (0.05%)  0/709 (0.00%) 
Mucosal inflammation * 1  1/1864 (0.05%)  0/709 (0.00%) 
Non- cardiac chest pain * 1  1/1864 (0.05%)  0/709 (0.00%) 
Oedema peripheral * 1  1/1864 (0.05%)  0/709 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  2/1864 (0.11%)  1/709 (0.14%) 
Cholecystitis chronic * 1  0/1864 (0.00%)  1/709 (0.14%) 
Immune system disorders     
Drug hypersensitivity * 1  2/1864 (0.11%)  0/709 (0.00%) 
Hypersensitivity * 1  0/1864 (0.00%)  2/709 (0.28%) 
Infections and infestations     
Neutropenic sepsis * 1  9/1864 (0.48%)  1/709 (0.14%) 
Device related infection * 1  6/1864 (0.32%)  0/709 (0.00%) 
Pneumonia * 1  5/1864 (0.27%)  1/709 (0.14%) 
Urinary tract infection * 1  3/1864 (0.16%)  2/709 (0.28%) 
Mastitis * 1  3/1864 (0.16%)  2/709 (0.28%) 
Cellulitis * 1  4/1864 (0.21%)  0/709 (0.00%) 
Gastroenteritis * 1  3/1864 (0.16%)  1/709 (0.14%) 
Lower respiratory tract infection * 1  4/1864 (0.21%)  0/709 (0.00%) 
Appendicitis * 1  2/1864 (0.11%)  1/709 (0.14%) 
Upper respiratory tract infection * 1  2/1864 (0.11%)  1/709 (0.14%) 
Breast abscess * 1  2/1864 (0.11%)  0/709 (0.00%) 
Erysipelas * 1  2/1864 (0.11%)  0/709 (0.00%) 
Infectious colitis * 1  2/1864 (0.11%)  0/709 (0.00%) 
Pyelonephritis acute * 1  2/1864 (0.11%)  0/709 (0.00%) 
Viral infection * 1  1/1864 (0.05%)  1/709 (0.14%) 
Infective exacerbation of chronic obstructive airways disease * 1  0/1864 (0.00%)  1/709 (0.14%) 
Abscess of external auditory meatus * 1  1/1864 (0.05%)  0/709 (0.00%) 
Appendiceal abscess * 1  1/1864 (0.05%)  0/709 (0.00%) 
Bartholin's abscess * 1  1/1864 (0.05%)  0/709 (0.00%) 
Breast cellulitis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Bronchitis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Bronchopneumonia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Clostridium difficile infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Dengue fever * 1  1/1864 (0.05%)  0/709 (0.00%) 
Diverticulitis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Febrile infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Gastroenteritis rotavirus * 1  0/1864 (0.00%)  1/709 (0.14%) 
Hepatitis B * 1  0/1864 (0.00%)  1/709 (0.14%) 
Herpes zoster * 1  1/1864 (0.05%)  0/709 (0.00%) 
Intestinal sepsis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Lobar pneumonia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Localised infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Lung infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Lymph node tuberculosis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Meningoencephalitis bacterial * 1  1/1864 (0.05%)  0/709 (0.00%) 
Periorbital cellulitis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Pneumonia bacterial * 1  1/1864 (0.05%)  0/709 (0.00%) 
Postoperative wound infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Pyelonephritis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Respiratory tract infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Skin infection * 1  0/1864 (0.00%)  1/709 (0.14%) 
Soft tissue infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Staphylococcal infection * 1  0/1864 (0.00%)  1/709 (0.14%) 
Tracheobronchitis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Urosepsis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Vaginal infection * 1  1/1864 (0.05%)  0/709 (0.00%) 
Wound infection * 1  0/1864 (0.00%)  1/709 (0.14%) 
Injury, poisoning and procedural complications     
Radiation pneumonitis * 1  2/1864 (0.11%)  0/709 (0.00%) 
Hip fracture * 1  1/1864 (0.05%)  1/709 (0.14%) 
Wound dehiscence * 1  0/1864 (0.00%)  1/709 (0.14%) 
Concussion * 1  1/1864 (0.05%)  0/709 (0.00%) 
Fibula fracture * 1  1/1864 (0.05%)  0/709 (0.00%) 
Fracture displacement * 1  1/1864 (0.05%)  0/709 (0.00%) 
Laceration * 1  0/1864 (0.00%)  1/709 (0.14%) 
Lumbar vertebral fracture * 1  1/1864 (0.05%)  0/709 (0.00%) 
Patella fracture * 1  0/1864 (0.00%)  1/709 (0.14%) 
Pelvic fracture * 1  1/1864 (0.05%)  0/709 (0.00%) 
Radius fracture * 1  1/1864 (0.05%)  0/709 (0.00%) 
Seroma * 1  1/1864 (0.05%)  0/709 (0.00%) 
Spinal fracture * 1  1/1864 (0.05%)  0/709 (0.00%) 
Tibia fracture * 1  1/1864 (0.05%)  0/709 (0.00%) 
Traumatic arthropathy * 1  0/1864 (0.00%)  1/709 (0.14%) 
Ulna fracture * 1  1/1864 (0.05%)  0/709 (0.00%) 
Wound * 1  1/1864 (0.05%)  0/709 (0.00%) 
Investigations     
Ejection fraction decreased * 1  3/1864 (0.16%)  0/709 (0.00%) 
White blood cell count decreased * 1  1/1864 (0.05%)  1/709 (0.14%) 
Blood urea increased * 1  1/1864 (0.05%)  0/709 (0.00%) 
Electrocardiogram QT prolonged * 1  1/1864 (0.05%)  0/709 (0.00%) 
Neutrophil count decreased * 1  1/1864 (0.05%)  0/709 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia * 1  2/1864 (0.11%)  0/709 (0.00%) 
Electrolyte imbalance * 1  1/1864 (0.05%)  0/709 (0.00%) 
Gout * 1  1/1864 (0.05%)  0/709 (0.00%) 
Hypokalaemia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Hyponatraemia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  2/1864 (0.11%)  0/709 (0.00%) 
Arthritis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Intervertebral disc protrusion * 1  1/1864 (0.05%)  0/709 (0.00%) 
Lumbar spinal stenosis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Myalgia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Rheumatoid arthritis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma * 1  1/1864 (0.05%)  2/709 (0.28%) 
Benign pancreatic neoplasm * 1  1/1864 (0.05%)  0/709 (0.00%) 
Borderline serous tumour of ovary * 1  1/1864 (0.05%)  0/709 (0.00%) 
Breast cancer * 1  1/1864 (0.05%)  0/709 (0.00%) 
Clear cell renal cell carcinoma * 1  1/1864 (0.05%)  0/709 (0.00%) 
Colon cancer * 1  0/1864 (0.00%)  1/709 (0.14%) 
Endometrial cancer * 1  1/1864 (0.05%)  0/709 (0.00%) 
Intraductal proliferative breast lesion * 1  1/1864 (0.05%)  0/709 (0.00%) 
Lung adenocarcinoma * 1  0/1864 (0.00%)  1/709 (0.14%) 
Ovarian fibroma * 1  1/1864 (0.05%)  0/709 (0.00%) 
Rectal adenocarcinoma * 1  1/1864 (0.05%)  0/709 (0.00%) 
Schwannoma * 1  1/1864 (0.05%)  0/709 (0.00%) 
Thyroid adenoma * 1  1/1864 (0.05%)  0/709 (0.00%) 
Nervous system disorders     
Headache * 1  2/1864 (0.11%)  0/709 (0.00%) 
Syncope * 1  1/1864 (0.05%)  1/709 (0.14%) 
Aphasia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Carotid sinus syndrome * 1  1/1864 (0.05%)  0/709 (0.00%) 
Cerebral ischaemia * 1  1/1864 (0.05%)  0/709 (0.00%) 
Cerebrovascular accident * 1  1/1864 (0.05%)  0/709 (0.00%) 
Depressed level of consciousness * 1  1/1864 (0.05%)  0/709 (0.00%) 
Epilepsy * 1  0/1864 (0.00%)  1/709 (0.14%) 
Generalised tonic-clonic seizure * 1  0/1864 (0.00%)  1/709 (0.14%) 
Peripheral sensorimotor neuropathy * 1  1/1864 (0.05%)  0/709 (0.00%) 
Presyncope * 1  1/1864 (0.05%)  0/709 (0.00%) 
Tension headache * 1  0/1864 (0.00%)  1/709 (0.14%) 
Transient ischaemic attack * 1  1/1864 (0.05%)  0/709 (0.00%) 
Psychiatric disorders     
Anxiety * 1  2/1864 (0.11%)  0/709 (0.00%) 
Depression * 1  1/1864 (0.05%)  1/709 (0.14%) 
Panic attack * 1  1/1864 (0.05%)  0/709 (0.00%) 
Psychotic disorder * 1  1/1864 (0.05%)  0/709 (0.00%) 
Renal and urinary disorders     
Renal failure * 1  2/1864 (0.11%)  0/709 (0.00%) 
Hydronephrosis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Urinary incontinence * 1  1/1864 (0.05%)  0/709 (0.00%) 
Urinary retention * 1  1/1864 (0.05%)  0/709 (0.00%) 
Reproductive system and breast disorders     
Uterine polyp * 1  2/1864 (0.11%)  0/709 (0.00%) 
Breast fibrosis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Endometrial hypertrophy * 1  1/1864 (0.05%)  0/709 (0.00%) 
Ovarian cyst * 1  1/1864 (0.05%)  0/709 (0.00%) 
Postmenopausal haemorrhage * 1  1/1864 (0.05%)  0/709 (0.00%) 
Uterine haemorrhage * 1  1/1864 (0.05%)  0/709 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  2/1864 (0.11%)  0/709 (0.00%) 
Dyspnoea * 1  2/1864 (0.11%)  0/709 (0.00%) 
Pneumonitis * 1  1/1864 (0.05%)  1/709 (0.14%) 
Pulmonary embolism * 1  0/1864 (0.00%)  2/709 (0.28%) 
Dyspnoea exertional * 1  0/1864 (0.00%)  1/709 (0.14%) 
Organising pneumonia * 1  0/1864 (0.00%)  1/709 (0.14%) 
Painful respiration * 1  1/1864 (0.05%)  0/709 (0.00%) 
Pleurisy * 1  0/1864 (0.00%)  1/709 (0.14%) 
Pulmonary oedema * 1  1/1864 (0.05%)  0/709 (0.00%) 
Respiratory failure * 1  1/1864 (0.05%)  0/709 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Dermatitis bullous * 1  0/1864 (0.00%)  1/709 (0.14%) 
Erythema nodosum * 1  0/1864 (0.00%)  1/709 (0.14%) 
Rash * 1  1/1864 (0.05%)  0/709 (0.00%) 
Toxic skin eruption * 1  0/1864 (0.00%)  1/709 (0.14%) 
Transient acantholytic dermatosis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Vascular disorders     
Hypertension * 1  2/1864 (0.11%)  0/709 (0.00%) 
Hypertensive crisis * 1  1/1864 (0.05%)  1/709 (0.14%) 
Aortic aneurysm * 1  1/1864 (0.05%)  0/709 (0.00%) 
Arterial stenosis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Deep vein thrombosis * 1  0/1864 (0.00%)  1/709 (0.14%) 
Orthostatic hypotension * 1  0/1864 (0.00%)  1/709 (0.14%) 
Phlebitis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Venous thrombosis * 1  1/1864 (0.05%)  0/709 (0.00%) 
Venous thrombosis limb * 1  1/1864 (0.05%)  0/709 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID
Affected / at Risk (%) Affected / at Risk (%)
Total   1499/1864 (80.42%)   576/709 (81.24%) 
Blood and lymphatic system disorders     
Anaemia * 1  130/1864 (6.97%)  43/709 (6.06%) 
Neutropenia * 1  101/1864 (5.42%)  36/709 (5.08%) 
Gastrointestinal disorders     
Diarrhoea * 1  380/1864 (20.39%)  130/709 (18.34%) 
Nausea * 1  274/1864 (14.70%)  102/709 (14.39%) 
Constipation * 1  153/1864 (8.21%)  62/709 (8.74%) 
Vomiting * 1  129/1864 (6.92%)  38/709 (5.36%) 
Stomatitis * 1  116/1864 (6.22%)  42/709 (5.92%) 
Abdominal pain * 1  87/1864 (4.67%)  36/709 (5.08%) 
Dyspepsia * 1  69/1864 (3.70%)  44/709 (6.21%) 
General disorders     
Fatigue * 1  381/1864 (20.44%)  132/709 (18.62%) 
Asthenia * 1  221/1864 (11.86%)  85/709 (11.99%) 
Pyrexia * 1  185/1864 (9.92%)  55/709 (7.76%) 
Oedema peripheral * 1  160/1864 (8.58%)  45/709 (6.35%) 
Injection site erythema * 1  128/1864 (6.87%)  52/709 (7.33%) 
Mucosal inflammation * 1  105/1864 (5.63%)  53/709 (7.48%) 
Injection site pain * 1  117/1864 (6.28%)  37/709 (5.22%) 
Injection site reaction * 1  101/1864 (5.42%)  36/709 (5.08%) 
Pain * 1  63/1864 (3.38%)  36/709 (5.08%) 
Infections and infestations     
Nasopharyngitis * 1  146/1864 (7.83%)  58/709 (8.18%) 
Upper respiratory tract infection * 1  113/1864 (6.06%)  21/709 (2.96%) 
Urinary tract infection * 1  94/1864 (5.04%)  32/709 (4.51%) 
Injury, poisoning and procedural complications     
Radiation skin injury * 1  161/1864 (8.64%)  68/709 (9.59%) 
Investigations     
Ejection fraction decreased * 1  80/1864 (4.29%)  36/709 (5.08%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  362/1864 (19.42%)  133/709 (18.76%) 
Myalgia * 1  260/1864 (13.95%)  84/709 (11.85%) 
Pain in extremity * 1  194/1864 (10.41%)  49/709 (6.91%) 
Back pain * 1  114/1864 (6.12%)  42/709 (5.92%) 
Musculoskeletal pain * 1  89/1864 (4.77%)  36/709 (5.08%) 
Bone pain * 1  70/1864 (3.76%)  40/709 (5.64%) 
Nervous system disorders     
Headache * 1  228/1864 (12.23%)  73/709 (10.30%) 
Neuropathy peripheral * 1  140/1864 (7.51%)  56/709 (7.90%) 
Paraesthesia * 1  112/1864 (6.01%)  70/709 (9.87%) 
Dizziness * 1  111/1864 (5.95%)  32/709 (4.51%) 
Peripheral sensory neuropathy * 1  94/1864 (5.04%)  21/709 (2.96%) 
Psychiatric disorders     
Insomnia * 1  108/1864 (5.79%)  50/709 (7.05%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  190/1864 (10.19%)  56/709 (7.90%) 
Dyspnoea * 1  115/1864 (6.17%)  47/709 (6.63%) 
Epistaxis * 1  109/1864 (5.85%)  30/709 (4.23%) 
Skin and subcutaneous tissue disorders     
Rash * 1  177/1864 (9.50%)  74/709 (10.44%) 
Erythema * 1  156/1864 (8.37%)  74/709 (10.44%) 
Alopecia * 1  163/1864 (8.74%)  49/709 (6.91%) 
Pruritus * 1  115/1864 (6.17%)  35/709 (4.94%) 
Vascular disorders     
Hot flush * 1  164/1864 (8.80%)  72/709 (10.16%) 
Hypertension * 1  142/1864 (7.62%)  35/709 (4.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01566721     History of Changes
Other Study ID Numbers: MO28048
2011-005328-17 ( EudraCT Number )
First Submitted: March 22, 2012
First Posted: March 29, 2012
Results First Submitted: March 6, 2017
Results First Posted: April 18, 2017
Last Update Posted: September 12, 2018