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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Trastuzumab subcutaneously
Drug: Trastuzumab intravenously
Biological: Recombinant humanized hyaluronidase
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 488
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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 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).
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401166

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01401166     History of Changes
Other Study ID Numbers: MO22982
Study First Received: July 22, 2011
Results First Received: February 9, 2015
Last Updated: June 3, 2015
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015