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
  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

  Hide Study Locations
Locations
Canada, Ontario
Barrie, Ontario, Canada, L4M 6M2
Brampton, Ontario, Canada, L6R 3J7
Kitchener, Ontario, Canada, N2G 1G3
Sault Ste Marie, Ontario, Canada, P6A 2C4
Toronto, Ontario, Canada, M4N 3M5
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Denmark
Herning, Denmark, 7400
Odense, Denmark, 5000
Vejle, Denmark, 7100
France
Besancon, France, 25030
Bobigny, France, 93009
Bordeaux, France, 33076
Caen, France, 14076
La Tronche, France, 38700
LeMans, France, 72000
Lyon, France, 69373
Paris, France, 75970
Rennes, France, 35042
St Cloud, France, 92210
Strasbourg, France, 67065
Germany
Berlin, Germany, 10713
Deggendorf, Germany, 94469
Essen, Germany, 45136
Fuerstenwalde, Germany, 15517
Hamburg, Germany, 20246
Hannover, Germany, 30625
Magedburg, Germany, 39104
Mainz, Germany, 55131
Meiningen, Germany, 98617
Recklinghausen, Germany, 45657
Ulm, Germany, 89073
Italy
Genova, Liguria, Italy, 16132
Milano, Lombardia, Italy, 20141
Milano, Lombardia, Italy, 20132
Pavia, Lombardia, Italy, 27100
Antella (FI), Toscana, Italy, 50011
Terni, Umbria, Italy, 05100
Poland
Gdansk, Poland, 80-952
Warszawa, Poland, 02-781
Russian Federation
Ekaterinburg, Russian Federation, 620905
Irkutsk, Russian Federation, 664035
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 115478
Orenburg, Russian Federation, 460021
Saint-Petersburg, Russian Federation, 197758
St Petersburg, Russian Federation
Spain
Oviedo, Asturias, Spain, 33006
Barakaldo, Vizcaya, Spain, 48903
Barcelona, Spain, 08024
Cordoba, Spain, 14004
Guadalajara, Spain, 19002
Huesca, Spain, 22004
Madrid, Spain, 28046
Madrid, Spain, 28905
Malaga, Spain, 29010
Sevilla, Spain, 41009
Sevilla, Spain, 41014
Zamora, Spain, 49021
Sweden
Eskilstuna, Sweden, 63188
Gävle, Sweden, 80187
Jonkoping, Sweden, 55185
Sundsvall, Sweden, 85186
Switzerland
Baden, Switzerland, 5405
Zürich, Switzerland, 8008
Turkey
Adana, Turkey, 01120
Ankara, Turkey, 06018
Bornova, ?ZM?R, Turkey, 35100
Gaziantep, Turkey, 27310
United Kingdom
Brighton, United Kingdom, BN2 5BE
Cardiff, United Kingdom, CF14 2TL
Chelmsford, United Kingdom, CM1 7ET
Maidstone, United Kingdom, ME16 9QQ
Nottingham, United Kingdom, NG5 1PB
Peterborough, United Kingdom, PE3 6DA
Truro, United Kingdom, TR1 3LJ
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: August 4, 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 August 28, 2014