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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: August 4, 2014
Last verified: August 2014

July 22, 2011
August 4, 2014
October 2011
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01401166 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study on Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in Patients With 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 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.

Not Provided
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 [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: A
    Interventions:
    • Drug: trastuzumab [Herceptin]
    • Drug: trastuzumab [Herceptin]
  • Experimental: B
    Interventions:
    • Drug: trastuzumab [Herceptin]
    • Drug: trastuzumab [Herceptin]
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
December 2015   (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 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
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, MO22982
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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