A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- Herceptin
- Conditions
- Breast Neoplasms
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 2577
- Locations
- 437
- Primary Endpoint
- Number of Herceptin Cycles Received
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%
Exclusion Criteria
- •Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
- •History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
- •Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
- •Metastatic disease
- •Inadequate bone marrow, hepatic, or renal function
- •Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- •History of severe allergic or immunological reactions, such as difficult-to-control asthma
- •Pregnant or lactating women
Arms & Interventions
Cohort A: SC Herceptin by Needle/Syringe
Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.
Intervention: Herceptin
Cohort B: SC Herceptin by SID
Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant.
Intervention: Herceptin
Outcomes
Primary Outcomes
Number of Herceptin Cycles Received
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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.
Percentage of Participants by Total Number of Herceptin Cycles Received
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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.
Percentage of Participants Who Received Concomitant Cancer Therapy
Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
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.
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
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.
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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.
Percentage of Participants With Treatment Interruption Due to an AE
Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
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.
Secondary Outcomes
- Percentage of Participants Who Died During the Safety Follow-up Period(From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years))
- Percentage of Participants Who Died by Data Cutoff of 10 March 2015(From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015))
- Disease-Free Survival Rate(From Baseline to time of event (up to approximately 8 years))
- Overall Survival Rate(From Baseline to Time of Event (Up to Approximately 6 Years))
- Percentage of Participants by Item Response to SID Satisfaction Questionnaire(Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year))