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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01401166
First received: July 22, 2011
Last updated: June 3, 2015
Last verified: June 2015

July 22, 2011
June 3, 2015
October 2011
May 2013   (final data collection date for primary outcome measure)
Participants' Preferred Method of Drug Administration [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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.
Proportion of patients indicating an overall preference for either the subcutaneous (SC) or the intravenous (IV) route of administration [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01401166 on ClinicalTrials.gov Archive Site
  • Healthcare Practitioners' Most Satisfied Method of Drug Administration [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.
  • Healthcare Practitioners' Perceived Time to Perform Each Method of Drug Administration [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.
  • Event-free Survival [ Time Frame: Baseline to the end of the study (up to 3 years, 2 weeks) ] [ Designated as safety issue: No ]
    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.
  • Participant Satisfaction With Subcutaneous Self-administration Using the Single-use Device [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.
  • Healthcare professional satisfaction with SC trastuzumab (Healthcare Professional Questionnaire) [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
  • Healthcare professional perceived time savings with SC trastuzumab (Healthcare Professional Questionnaire) [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Event-free survival, assessed as per institutional practice or according to the American Society of Clinical Oncology (ASCO) Guideline Breast Cancer Follow-up 2006 [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Immunogenicity (trastuzumab, recombinant human hyaluronidase) [ Time Frame: from baseline to Week 13 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer
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)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Trastuzumab subcutaneously
    Trastuzumab subcutaneously was supplied in either a single-use injection device or in vials for injection with a hand-held syringe.
    Other Name: Herceptin
  • Drug: Trastuzumab intravenously
    Trastuzumab intravenously was provided in vials as a freeze-dried lyophilisate.
    Other Name: Herceptin
  • 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.
  • Experimental: Trastuzumab subcutaneously then trastuzumab intravenously
    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).
    Interventions:
    • Drug: Trastuzumab subcutaneously
    • Drug: Trastuzumab intravenously
    • Biological: Recombinant humanized hyaluronidase
  • Experimental: Trastuzumab intravenously then trastuzumab subcutaneously
    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).
    Interventions:
    • Drug: Trastuzumab subcutaneously
    • Drug: Trastuzumab intravenously
    • Biological: Recombinant humanized hyaluronidase
Pivot X, Gligorov J, Müller V, Curigliano G, Knoop A, Verma S, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014 Oct;25(10):1979-87. doi: 10.1093/annonc/mdu364. Epub 2014 Jul 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
488
December 2015
May 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   France,   Germany,   Italy,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT01401166
MO22982
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP