A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 488
- Primary Endpoint
- Percentage of Participants by Preferred Method of Drug Administration
Overview
Brief Summary
This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed HER2-positive primary breast cancer
- •No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)
- •Completed neo-adjuvant chemotherapy prior to entry, if received
- •At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
- •History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years
- •Inadequate bone marrow function
- •Impaired liver function
- •Inadequate renal function
- •Serious cardiovascular disease
- •Human immunodeficiency virus or hepatitis B or C infection
- •Prior maximum cumulative dose of doxorubicin greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or equivalent
Arms & Interventions
Cohort 1: SC (SID) then IV Herceptin
Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.
Intervention: Herceptin (Drug)
Cohort 1: SC (SID) then IV Herceptin
Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.
Intervention: Single-Use Injection Device (Device)
Cohort 1: IV then SC (SID) Herceptin
Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via SID. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.
Intervention: Herceptin (Drug)
Cohort 1: IV then SC (SID) Herceptin
Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via SID. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.
Intervention: Single-Use Injection Device (Device)
Cohort 2: SC (Vial) then IV Herceptin
Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.
Intervention: Herceptin (Drug)
Cohort 2: IV then SC (Vial) Herceptin
Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via handheld syringe using the vial formulation. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.
Intervention: Herceptin (Drug)
Outcomes
Primary Outcomes
Percentage of Participants by Preferred Method of Drug Administration
Time Frame: Week 24
The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.
Secondary Outcomes
- Percentage of HCPs by Most Satisfied Method of Drug Administration(Week 24)
- Percentage of HCPs by Time Required to Perform Each Method of Drug Administration(Week 24)
- Percentage of Participants With an Event-Free Survival (EFS) Event(From Baseline until time of event; assessed every 6 months (median follow-up of 3 years))
- Duration of EFS According to Kaplan-Meier Estimate(From Baseline until time of event; assessed every 6 months (median follow-up of 3 years))
- 3-Year EFS Rate(Year 3)
- Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire(Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52))
- Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies(Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks))