Clinical trial NCT01401166: Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
Official title: A Randomized, Multi-Center 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 488
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed HER2-positive primary breast cancer
* No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)
* Completed neo-adjuvant chemotherapy prior to entry, if received
* At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin
* 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, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years
* Inadequate bone marrow function
* Impaired liver function
* Inadequate renal function
* Serious cardiovascular disease
* Human immunodeficiency virus or hepatitis B or C infection
* Prior maximum cumulative dose of doxorubicin greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or equivalent

Primary outcomes:
measure: Percentage of Participants by Preferred Method of Drug Administration
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of HCPs by Most Satisfied Method of Drug Administration
timeFrame: Week 24
measure: Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
timeFrame: Week 24
measure: Percentage of Participants With an Event-Free Survival (EFS) Event
timeFrame: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
measure: Duration of EFS According to Kaplan-Meier Estimate
timeFrame: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
measure: 3-Year EFS Rate
timeFrame: Year 3
measure: Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
timeFrame: Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)
measure: Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
timeFrame: Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)
Other outcomes:
Locations:
city: Barrie
country: Canada
state: Ontario
city: Brampton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Sault Ste Marie
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Herning
country: Denmark
city: Odense
country: Denmark
city: Vejle
country: Denmark
city: Besancon
country: France
city: Bobigny
country: France
city: Bordeaux
country: France
city: Caen
country: France
city: La Tronche
country: France
city: LeMans
country: France
city: Lyon
country: France
city: Paris
country: France
city: Rennes
country: France
city: St Cloud
country: France
city: Strasbourg
country: France
city: Berlin
country: Germany
city: Deggendorf
country: Germany
city: Essen
country: Germany
city: Fuerstenwalde
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Magedburg
country: Germany
city: Mainz
country: Germany
city: Meiningen
country: Germany
city: Recklinghausen
country: Germany
city: Ulm
country: Germany
city: Genova
country: Italy
state: Liguria
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Antella (FI)
country: Italy
state: Toscana
city: Terni
country: Italy
state: Umbria
city: Gdansk
country: Poland
city: Warszawa
country: Poland
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Oviedo
country: Spain
state: Asturias
city: Barakaldo
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Guadalajara
country: Spain
city: Huesca
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Zamora
country: Spain
city: Eskilstuna
country: Sweden
city: Gävle
country: Sweden
city: Jonkoping
country: Sweden
city: Sundsvall
country: Sweden
city: Baden
country: Switzerland
city: Zürich
country: Switzerland
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Bornova, ?ZM?R
country: Turkey
city: Gaziantep
country: Turkey
city: Brighton
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Chelmsford
country: United Kingdom
city: Maidstone
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Peterborough
country: United Kingdom
city: Truro
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pivot X, Verma S, Fallowfield L, Muller V, Lichinitser M, Jenkins V, Sanchez Munoz A, Machackova Z, Osborne S, Gligorov J; PrefHer Study Group. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017 Nov;86:82-90. doi: 10.1016/j.ejca.2017.08.019. Epub 2017 Sep 28.
citation: Gligorov J, Curigliano G, Muller V, Knoop A, Jenkins V, Verma S, Osborne S, Lauer S, Machackova Z, Fallowfield L, Pivot X. Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial. Breast. 2017 Aug;34:89-95. doi: 10.1016/j.breast.2017.05.004. Epub 2017 May 23.
citation: De Cock E, Pivot X, Hauser N, Verma S, Kritikou P, Millar D, Knoop A. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016 Mar;5(3):389-97. doi: 10.1002/cam4.573. Epub 2016 Jan 25.
citation: Pivot X, Gligorov J, Muller 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):1979-1987. doi: 10.1093/annonc/mdu364. Epub 2014 Jul 28.
citation: Pivot X, Gligorov J, Muller V, Barrett-Lee P, Verma S, Knoop A, Curigliano G, Semiglazov V, Lopez-Vivanco G, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013 Sep;14(10):962-70. doi: 10.1016/S1470-2045(13)70383-8. Epub 2013 Aug 19.