This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,577
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania
CPMC; Service d'Oncologie Médicale
Algiers, Algeria
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, Argentina
Hospital Britanico; Oncologia
Buenos Aires, Argentina
Instituto De Investigaciones Clinicas Zarate
Zárate, Argentina
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
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)
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
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)
Percentage of Participants With Treatment Interruption Due to an AE
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)
Number of Herceptin Cycles Received
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)
Percentage of Participants by Total Number of Herceptin Cycles Received
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)
Percentage of Participants Who Received Concomitant Cancer Therapy
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)
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
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)
Percentage of Participants Who Died by Data Cutoff of 10 March 2015
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)
Percentage of Participants Who Died During the Safety Follow-up Period
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)
Disease-Free Survival Rate
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)
Overall Survival Rate
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)
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
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.
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Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
St George Hospital; Cancer Care Centre
Kogarah, New South Wales, Australia
Prince of Wales Hospital; Oncology
Randwick, New South Wales, Australia
Princess Alexandra Hospital; Division of Cancer Services
Woolloongabba, Queensland, Australia
Queen Elizabeth Hospital; Medical Oncology
Woodville South, South Australia, Australia
...and 427 more locations
Time frame: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)