Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01401166
• Other study ID #: MO22982
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 22, 2011
• Last updated: June 3, 2015
• Start date: October 2011
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 488
• Est. completion date: December 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab subcutaneously
Trastuzumab subcutaneously was supplied in either a single-use injection device or in vials for injection with a hand-held syringe.
• Trastuzumab intravenously
Trastuzumab intravenously was provided in vials as a freeze-dried lyophilisate.

Biological:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Germany,  Italy,  Poland,  Russian Federation,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' Preferred Method of Drug Administration	The preferred method of drug administration, intravenous or subcutaneous, was assessed in trial-specific telephone interviews with each study participant conducted after the end of the crossover period. Specifically, the participant was asked "All things considered, which method of administration did you prefer?" Reported is the percentage of participants who preferred each method of drug administration.	Week 24	No
Secondary	Healthcare Practitioners' Most Satisfied Method of Drug Administration	The method of drug administration with which healthcare practitioners were most satisfied, intravenous or subcutaneous, was assessed at the end of the crossover period by the response to the question in the healthcare practitioner questionnaire "All things considered, with which method of administration were you most satisfied?". Reported is the percentage of healthcare practitioners who were most satisfied with each method of drug administration.	Week 24	No
Secondary	Healthcare Practitioners' Perceived Time to Perform Each Method of Drug Administration	Healthcare professionals were asked to rate the amount of time it took to administer trastuzumab subcutaneously and intravenously in the following time block categories: < 5, 6-10, 11-15, 16-20, > 20 minutes, Not sure, and Unknown. Reported is the percentage of healthcare practitioners who rated the amount of time in each of the categories.	Week 24	No
Secondary	Event-free Survival	Event-free survival is defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. As event-free survival is a long-term Outcome Measure and participants have received trastuzumab both intravenously and subcutaneously, the results are presented for all participants as a single group.	Baseline to the end of the study (up to 3 years, 2 weeks)	No
Secondary	Participant Satisfaction With Subcutaneous Self-administration Using the Single-use Device	Following the crossover period, participants in Cohort 1 who had at least 2 of the total of 18 treatment cycles remaining, were offered the opportunity to self-administer trastuzumab subcutaneously using the single-use injection device under the supervision of a healthcare provider. Of the = 2 treatment cycles remaining, one was used by the healthcare provider to train the patient. Patients were given an evaluation questionnaire after their first self-administration. Participants answered 5 questions using a 5-item rating scale: Strongly disagree, disagree, unsure, agree, strongly agree. Responses to the 5 questions rated their comfort with self-injection, the convenience of the single-use device, their self-confidence using the single-use device, their satisfaction with the single-use device, and whether they would consider using the single-use device again in the future.	Week 24	No