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AzTrials

Breast NeoplasmsPhase 2PrefHERNCT01401166

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

A Phase 2 study testing Herceptin and Single-Use Injection Device in people with Breast Neoplasms, run by Hoffmann-La Roche at 75 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Herceptin and Single-Use Injection Device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
75 sitesin 12 countries
Study dates
Oct 2011to Dec 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

75 sites in 12 countries.

75 sites in 12 countries

Spain12 sites

  • Study site

    Barakaldo, Vizcaya, 48903

  • Study site

    Barcelona, Barcelona, 08024

  • Study site

    Córdoba, Cordoba, 14004

  • Study site

    Guadalajara, Guadalajara, 19002

  • Study site

    Huesca, Huesca, 22004

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Madrid, Madrid, 28905

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Seville, Sevilla, 41009

  • Study site

    Seville, Sevilla, 41014

  • Study site

    Zamora, Zamora, 49021

Other trials in Spain

France11 sites

  • Study site

    Besançon, 25030

  • Study site

    Bobigny, 93009

  • Study site

    Bordeaux, 33076

  • Study site

    Caen, 14076

  • Study site

    La Tronche, 38700

  • Study site

    LeMans, 72000

  • Study site

    Lyon, 69373

  • Study site

    Paris, 75970

  • Study site

    Rennes, 35042

  • Study site

    Saint-Cloud, 92210

  • Study site

    Strasbourg, 67065

Other trials in France

Germany11 sites

  • Study site

    Berlin, 10713

  • Study site

    Deggendorf, 94469

  • Study site

    Essen, 45136

  • Study site

    Fürstenwalde, 15517

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, 30625

  • Study site

    Magedburg, 39104

  • Study site

    Mainz, 55131

  • Study site

    Meiningen, 98617

  • Study site

    Recklinghausen, 45657

  • Study site

    Ulm, 89073

Other trials in Germany

Russia7 sites

  • Study site

    Irkutsk, 664035

  • Study site

    Kazan', 420029

  • Study site

    Moscow, 115478

  • Study site

    Orenburg, 460021

  • Study site

    Saint Petersburg, 197758

  • Study site

    Saint Petersburg

  • Study site

    Yekaterinburg, 620905

Other trials in Russia

United Kingdom7 sites

  • Study site

    Brighton, BN2 5BE

  • Study site

    Cardiff, CF14 2TL

  • Study site

    Chelmsford, CM1 7ET

  • Study site

    Maidstone, ME16 9QQ

  • Study site

    Nottingham, NG5 1PB

  • Study site

    Peterborough, PE3 6DA

  • Study site

    Truro, TR1 3LJ

Other trials in United Kingdom

Canada6 sites

  • Study site

    Barrie, Ontario, L4M 6M2

  • Study site

    Brampton, Ontario, L6R 3J7

  • Study site

    Kitchener, Ontario, N2G 1G3

  • Study site

    Saskatoon, Saskatchewan, S7N 4H4

  • Study site

    Sault Ste. Marie, Ontario, P6A 2C4

  • Study site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Italy6 sites

  • Study site

    Antella (FI), Tuscany, 50011

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20141

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Terni, Umbria, 05100

Other trials in Italy

Sweden4 sites

  • Study site

    Eskilstuna, 63188

  • Study site

    Gävle, 80187

  • Study site

    Jönköping, 55185

  • Study site

    Sundsvall, 85186

Other trials in Sweden

Turkey (Türkiye)4 sites

  • Study site

    Adana, 01120

  • Study site

    Ankara, 06018

  • Study site

    Bornova, ?zm?r, 35100

  • Study site

    Gaziantep, 27310

Other trials in Turkey (Türkiye)

Denmark3 sites

  • Study site

    Herning, 7400

  • Study site

    Odense, 5000

  • Study site

    Vejle, 7100

Other trials in Denmark

Poland2 sites

  • Study site

    Gdansk, 80-952

  • Study site

    Warsaw, 02-781

Other trials in Poland

Switzerland2 sites

  • Study site

    Baden, 5405

  • Study site

    Zurich, 8008

Other trials in Switzerland

About this study

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)

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.

Being tested
Herceptin, Single-Use Injection Device
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HerceptinDrug

    Also called Trastuzumab

    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.

  • HerceptinDrug

    Also called Trastuzumab

    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 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 mg for both the SID and vial formulations for all cycles where SC Herceptin is given.

  • Single-Use Injection DeviceDevice

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

  • Single-Use Injection DeviceDevice

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

Study groups in NCT01401166
Study groupRoleWhat they receive
Cohort 1: SC (SID) then IV HerceptinExperimentalParticipants 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.
Receives: Drug: Herceptin; Device: Single-Use Injection Device
Cohort 1: IV then SC (SID) HerceptinExperimentalParticipants 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.
Receives: Drug: Herceptin; Device: Single-Use Injection Device
Cohort 2: SC (Vial) then IV HerceptinExperimentalParticipants 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.
Receives: Drug: Herceptin
Cohort 2: IV then SC (Vial) HerceptinExperimentalParticipants 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.
Receives: Drug: Herceptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (7)

  1. Percentage of HCPs by Most Satisfied Method of Drug Administration

    The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, "All things considered, with which method of administration were you most satisfied?" at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.

    Measured: Week 24

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

    The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (>) 20 minutes. Responses of "Not Sure" and "Unknown" were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported.

    Measured: Week 24

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

    EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.

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

  4. Duration of EFS According to Kaplan-Meier Estimate

    EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.

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

  5. 3-Year EFS Rate

    EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.

    Measured: Year 3

  6. Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire

    Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from "Strongly Disagree" to "Strongly Agree". The percentage of participants with a positive response (either "Agree" or "Strongly Agree") to each questionnaire statement was reported.

    Measured: Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)

  7. Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies

    Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.

    Measured: Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMay 2013
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01401166
Sponsor's protocol ID
MO22982
Other IDs
2010-024099-25
Acronym
PrefHER
Status last verified
Jan 2017
First submitted
22 Jul 2011
Last updated
6 Mar 2017

Publications

  • 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.

    PubMed 28963915

  • 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.

    PubMed 28549309

  • 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.

    PubMed 26806010

  • 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.

    PubMed 25070545

  • 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.

    PubMed 23965225

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Herceptin and Single-Use Injection Device in people with Breast Neoplasms, run by Hoffmann-La Roche at 75 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Spain, France, Germany, Russia, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants by Preferred Method of Drug Administration (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01401166, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.

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