A Study on Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in Patients With 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: July 14, 2014
Last verified: July 2014
  Purpose

This randomized, open-label, crossover study will evaluate patients' preference and healthcare professional satisfaction with Herceptin (trastuzumab) subcutaneo us (sc) versus intravenous (iv) administration in patients with HER2-positive ea rly breast cancer. Patients will be randomized to receive either Herceptin 600 m g sc or Herceptin 6 mg/kg iv every 3 weeks for Cycles 1-4, then cross over to th e other treatment administration for Cycles 5-8. For Cycles 9-22, all patients w ill be administered iv Herceptin at 6 mg/kg every 3 weeks. Anticipated time on s tudy treatment is 66 weeks.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 488
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: trastuzumab [Herceptin]
600 mg subcutaneously every 3 weeks, cycles 1-4 (Arm A) or 5-8 (Arm B)
Drug: trastuzumab [Herceptin]
6 mg/kg intravenously (iv) every 3 weeks, cycles 1-4 (Arm B) or cycles 5-8 (Arm A), and cycles 9-22 (Arms A and B)
Experimental: B Drug: trastuzumab [Herceptin]
600 mg subcutaneously every 3 weeks, cycles 1-4 (Arm A) or 5-8 (Arm B)
Drug: trastuzumab [Herceptin]
6 mg/kg intravenously (iv) every 3 weeks, cycles 1-4 (Arm B) or cycles 5-8 (Arm A), and cycles 9-22 (Arms A and B)

  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 IV Herceptin must have at least 10 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 cardio-vascular disease
  • HIV or hepatitis B (HBV) or C (HCV) infection
  • Prior maximum cumulative dose of doxorubicin > 360 mg/m2 or epirubicin > 720 mg/m2 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

  Show 75 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01401166     History of Changes
Other Study ID Numbers: MO22982, MO22982
Study First Received: July 22, 2011
Last Updated: July 14, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on July 28, 2014