Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab subcutaneously, trastuzumab intravenously, recombinant humanized hyaluronidase
Phase phase 2
Sponsor Hoffmann-La Roche
Start date October 2011
End date May 2013
Trial size 488 participants
Trial identifier NCT01401166, MO22982

Summary

This randomized, open-label, crossover study evaluated participants' preference and healthcare professional satisfaction with trastuzumab (Herceptin) subcutaneous (sc) versus intravenous (iv) administration in participants with HER2-positive early breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants received trastuzumab on Day 1 of each 3-week cycle for 18 cycles. During cycles 1-4 of the crossover period, they received trastuzumab 600 mg subcutaneously (SC) and during cycles 5-8, they received trastuzumab 6 mg/kg intravenously (IV). In the other 10 cycles, participants received either trastuzumab 6 mg/kg IV (Cohort 1) or trastuzumab 600 mg SC vial (Cohort 2).
trastuzumab subcutaneously Herceptin
Trastuzumab subcutaneously was supplied in either a single-use injection device or in vials for injection with a hand-held syringe.
trastuzumab intravenously Herceptin
Trastuzumab intravenously was provided in vials as a freeze-dried lyophilisate.
recombinant humanized hyaluronidase
Both the single-use injection device and the vials for injection with a hand-held syringe contained 2000 units/mL of recombinant humanized hyaluronidase as a permeation enhancer.
(Experimental)
Participants received trastuzumab on Day 1 of each 3-week cycle for 18 cycles. During cycles 1-4 of the crossover period, they received trastuzumab 6 mg/kg intravenously (IV) and during cycles 5-8, they received trastuzumab 600 mg subcutaneously (SC). In case Cycle 1 of the crossover period was the first cycle of trastuzumab treatment, a loading dose of trastuzumab 8 mg/kg IV was administered. In the other 10 cycles, participants received either trastuzumab 6 mg/kg IV (Cohort 1) or trastuzumab 600 mg SC vial (Cohort 2).
trastuzumab subcutaneously Herceptin
Trastuzumab subcutaneously was supplied in either a single-use injection device or in vials for injection with a hand-held syringe.
trastuzumab intravenously Herceptin
Trastuzumab intravenously was provided in vials as a freeze-dried lyophilisate.
recombinant humanized hyaluronidase
Both the single-use injection device and the vials for injection with a hand-held syringe contained 2000 units/mL of recombinant humanized hyaluronidase as a permeation enhancer.

Primary Outcomes

Measure
Participants' Preferred Method of Drug Administration
time frame: Week 24

Secondary Outcomes

Measure
Healthcare Practitioners' Most Satisfied Method of Drug Administration
time frame: Week 24
Healthcare Practitioners' Perceived Time to Perform Each Method of Drug Administration
time frame: Week 24
Event-free Survival
time frame: Baseline to the end of the study (up to 3 years, 2 weeks)
Participant Satisfaction With Subcutaneous Self-administration Using the Single-use Device
time frame: Week 24

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female patients, ≥ 18 years of age. - HER2-positive breast cancer. - No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant). - All adjuvant chemotherapy must be completed; adjuvant radiotherapy may be ongoing. - Patients who have already received intravenous Herceptin must have at least 8 out of the total planned 18 3-week cycles remaining. - 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 or basal cell carcinoma, or other curatively treated malignancies that have been disease-free for at least 5 years. - Inadequate bone marrow function. - Impaired liver function. - Inadequate renal function. - Serious cardiovascular disease. - Human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV) infection. - Prior maximum cumulative dose of doxorubicin > 360 mg/m^2 or epirubicin > 720 mg/m^2 or equivalent.

Additional Information

Official title A Randomized, Multi-centre 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)
Description Participants were randomized to receive either trastuzumab 600 mg SC or trastuzumab 6 mg/kg IV every 3 weeks for Cycles 1-4, then crossover to the other treatment administration for Cycles 5-8. For the remaining up to 10 cycles, participants in Cohort 1 were administered trastuzumab 6 mg/kg IV every 3 weeks and participants in Cohort 2 were administered trastuzumab 600 mg SC every 3 weeks. Participants in Cohort 1, who had at least 2 treatment cycles remaining of their 18-cycle treatment course after the crossover period, were offered the opportunity to self-administer trastuzumab 600 mg subcutaneously using the single-injection device on Day 1 of each 3-week cycle under the direction of a trained health care practitioner.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.