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Breast CancerPhase 3HOMERUSNCT02040935

A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants

A Phase 3 study testing Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 17 sites in Netherlands.

Completed

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

Official record
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Trial summary

This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
17 sitesNetherlands
Study dates
21 Feb 2014to 14 Sep 2018
Phase
Phase 3
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
  • HER2-positive disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Hormonal therapy will be allowed as per institutional guidelines
  • Prior use of anti-HER2 therapy will be allowed
  • Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
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  • No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
  • Use of concurrent radiotherapy will be permitted
  • Completion of surgery and chemotherapy (if applicable)

Who cannot join

  • History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years
  • Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
  • Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
  • Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
  • Pregnant or lactating women
  • Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
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  • Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
  • Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
  • Inadequate hepatic or renal function

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Netherlands17 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Meander Medisch Centrum; Locatie Lichtenberg

    Amersfoort, 3818 ES

  • Amphia ziekenhuis, locatie langendijk

    Breda, 4819 EV

  • IJsselland Ziekenhuis

    Capelle aan den IJssel, 2906 ZC

  • Reinier de Graaf Gasthuis; Oncology

    Delft, 2600 GA

  • Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde

    Ede, 6716 RP

  • Martini Ziekenhuis

    Groningen, 9728 MG

  • Kennemer Gasthuis

    Haarlem, 2035 RC

  • Ziekenhuisgroep Twente, Hengelo

    Hengelo, 7555 DL

  • Tergooiziekenhuizen, loc. Hilversum

    Hilversum, 1213 HX

  • Spaarne Ziekenhuis Haarlem; Oncologie

    Hoofddorp, 2134 TM

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3430 EM

  • Franciscus Ziekenhuis

    Roosendaal, 4708 AE

  • Zuyderland ziekenhuis locatie Geleen

    Sittard-Geleen, 6162 BG

  • Haga Ziekenhuis

    The Hague, 2504 LN

  • VieCuri - Medisch Centrum voor Noord-Limburg

    Venlo, 5912 BL

  • Isala Klinieken

    Zwolle, 8011 JW

Other trials in Netherlands

About this study

Official title: HOMERUS: A Local, Open Label, Multicentre, Phase IIIB Study, Investigating Subcutaneous Trastuzumab Administered at Home With Single Injection Device in Patients With HER2-Positive Early Breast Cancer

This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).

Conditions
Breast Cancer
Being tested
Trastuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TrastuzumabDrug

    Also called Herceptin

    600 mg SC Q3W by SID

Study groups in NCT02040935
Study groupRoleWhat they receive
TrastuzumabExperimentalParticipants will receive 600 milligrams (mg) trastuzumab SC by SID every 3 weeks (Q3W) for up to a total of 1 year, unless disease recurrence, unacceptable toxicity or participant withdrawal occurs. The first 3 administrations will be done at hospital, after that participants will be permitted to self-administer under the supervision of a healthcare professional (HCP).
Receives: Drug: Trastuzumab

What is being measured

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

  1. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    Measured: From Baseline up to approximately 4 years

Secondary outcomes (4)

  1. Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab

    Measured: Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)

  2. Health Survey Short Form-36 (SF-36) Score

    Measured: Cycles 3 and 9 (cycle length=21 days)

  3. Mood and Anxiety Questionnaire (MASQ) Score

    Measured: Cycles 3 and 9 (cycle length=21 days)

  4. Percentage of Participants Choosing to Return to Hospital Administration

    Measured: Cycle 6 (cycle length=21 days)

Timeline

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

  1. First posted20 Jan 2014 (estimated)
  2. Study start21 Feb 2014
  3. Primary completion14 Sep 2018
  4. Study completion14 Sep 2018

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02040935
Sponsor's protocol ID
ML28878
Other IDs
2013-000829-31
Acronym
HOMERUS
Status last verified
Aug 2019
First submitted
15 Jan 2014
Last updated
22 Aug 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 17 sites in Netherlands.

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 9 inclusion and 9 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 With Adverse Events (AEs) and Serious AEs (SAEs) (time frame: From Baseline up to approximately 4 years). 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 NCT02040935.

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 22 Aug 2019.

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