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

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)

Population: 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.

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)

Population: 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.

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)

Population: Safety Population

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)

Population: Safety Population

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)

Population: Safety Population

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)

Population: Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.

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)

Population: Safety Population

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 from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.

Time frame: From Baseline to time of event (up to approximately 8 years)

Population: ITT Population who completed Safety Follow-up

Overall survival was defined as the time from randomization to death from any cause. Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.

Time frame: From Baseline to Time of Event (Up to Approximately 6 Years)

Population: ITT population: All randomized participants received at least one dose of drug and completed the follow up period

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)

Population: 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.

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)

Population: ITT Population

The percentage of participants who died from any cause was reported during the safety follow-up period.

Time frame: From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)

Population: ITT Population