Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

NCT01401166 | Completed Phase 2 Results

• 2 other identifiers: MO229822010-024099-25
• Study Type: interventional
• Target: 488
• Locations: 12 countries
• Sites: 75

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants by Preferred Method of Drug Administration

  The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.

  Week 24

Secondary Outcomes (7)

• Percentage of HCPs by Most Satisfied Method of Drug Administration

  Week 24

• Percentage of HCPs by Time Required to Perform Each Method of Drug Administration

  Week 24

• Percentage of Participants With an Event-Free Survival (EFS) Event

  From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)

• Duration of EFS According to Kaplan-Meier Estimate

  From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)

• 3-Year EFS Rate

  Year 3

Study Arms (4)

Cohort 1: SC (SID) then IV Herceptin

EXPERIMENTAL

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.

Drug: Herceptin; Device: Single-Use Injection Device

Cohort 1: IV then SC (SID) Herceptin

EXPERIMENTAL

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via SID. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.

Drug: Herceptin; Device: Single-Use Injection Device

Cohort 2: SC (Vial) then IV Herceptin

EXPERIMENTAL

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.

Drug: Herceptin

Cohort 2: IV then SC (Vial) Herceptin

EXPERIMENTAL

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via handheld syringe using the vial formulation. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.

Drug: Herceptin

Interventions

Herceptin DRUG

Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 milligrams per kilogram (mg/kg) for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 milligrams (mg) for both the SID and vial formulations for all cycles where SC Herceptin is given.

Also known as: Trastuzumab

Cohort 1: SC (SID) then IV Herceptin

Single-Use Injection Device DEVICE

The SID will be used, containing Herceptin 600 mg per 5 milliliters (mL).

Cohort 1: SC (SID) then IV Herceptin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (75)

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Barrie, Ontario, L4M 6M2, Canada

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Brampton, Ontario, L6R 3J7, Canada

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Kitchener, Ontario, N2G 1G3, Canada

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Sault Ste. Marie, Ontario, P6A 2C4, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Saskatoon, Saskatchewan, S7N 4H4, Canada

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Herning, 7400, Denmark

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Odense, 5000, Denmark

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Vejle, 7100, Denmark

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Besançon, 25030, France

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Bobigny, 93009, France

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Bordeaux, 33076, France

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Caen, 14076, France

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La Tronche, 38700, France

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LeMans, 72000, France

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Lyon, 69373, France

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Paris, 75970, France

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Rennes, 35042, France

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Saint-Cloud, 92210, France

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Strasbourg, 67065, France

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Berlin, 10713, Germany

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Deggendorf, 94469, Germany

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Essen, 45136, Germany

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Fürstenwalde, 15517, Germany

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

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Magedburg, 39104, Germany

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Mainz, 55131, Germany

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Meiningen, 98617, Germany

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Recklinghausen, 45657, Germany

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Ulm, 89073, Germany

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Genoa, Liguria, 16132, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20141, Italy

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Pavia, Lombardy, 27100, Italy

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Antella (FI), Tuscany, 50011, Italy

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Terni, Umbria, 05100, Italy

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Gdansk, 80-952, Poland

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Warsaw, 02-781, Poland

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Irkutsk, 664035, Russia

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Kazan', 420029, Russia

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Moscow, 115478, Russia

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Orenburg, 460021, Russia

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Saint Petersburg, 197758, Russia

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Saint Petersburg, Russia

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Yekaterinburg, 620905, Russia

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Barcelona, Barcelona, 08024, Spain

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Córdoba, Cordoba, 14004, Spain

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Guadalajara, Guadalajara, 19002, Spain

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Huesca, Huesca, 22004, Spain

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Madrid, Madrid, 28046, Spain

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Madrid, Madrid, 28905, Spain

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Málaga, Malaga, 29010, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Seville, Sevilla, 41009, Spain

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Seville, Sevilla, 41014, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Zamora, Zamora, 49021, Spain

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Eskilstuna, 63188, Sweden

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Gävle, 80187, Sweden

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Jönköping, 55185, Sweden

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Sundsvall, 85186, Sweden

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Baden, 5405, Switzerland

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Zurich, 8008, Switzerland

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Adana, 01120, Turkey (Türkiye)

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Ankara, 06018, Turkey (Türkiye)

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Bornova, ?zm?r, 35100, Turkey (Türkiye)

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Gaziantep, 27310, Turkey (Türkiye)

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Brighton, BN2 5BE, United Kingdom

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Cardiff, CF14 2TL, United Kingdom

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Chelmsford, CM1 7ET, United Kingdom

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Maidstone, ME16 9QQ, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Peterborough, PE3 6DA, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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Related Publications (5)

• 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.

  PMID: 28963915 DERIVED

• 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.

  PMID: 28549309 DERIVED

• 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.

  PMID: 26806010 DERIVED

• 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.

  PMID: 25070545 DERIVED

• 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.

  PMID: 23965225 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 25, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2015
• Last Updated: March 6, 2017
• Results First Posted: June 8, 2015

Record last verified: 2017-01

Locations

DK (3); TU (4); IT (6); ES (12); PL (2); FR (11); CA (6); RU (7); SE (4); DE (11); CH (2); GB (7)