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

August 21, 2019 updated by: Hoffmann-La Roche

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar
      • Amersfoort, Netherlands, 3818 ES
        • Meander Medisch Centrum; Locatie Lichtenberg
      • Breda, Netherlands, 4819 EV
        • Amphia ziekenhuis, locatie langendijk
      • Capelle Aan De Yssel, Netherlands, 2906 ZC
        • IJsselland ziekenhuis
      • Delft, Netherlands, 2600 GA
        • Reinier de Graaf Gasthuis; Oncology
      • Den Haag, Netherlands, 2504 LN
        • Haga Ziekenhuis
      • EDE, Netherlands, 6716 RP
        • Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde
      • Groningen, Netherlands, 9728 MG
        • Martini Ziekenhuis
      • Haarlem, Netherlands, 2035 RC
        • Kennemer Gasthuis
      • Hengelo, Netherlands, 7555 DL
        • Ziekenhuisgroep Twente, Hengelo
      • Hilversum, Netherlands, 1213 HX
        • Tergooiziekenhuizen, loc. Hilversum
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis Haarlem; Oncologie
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis Nieuwegein
      • Roosendaal, Netherlands, 4708 AE
        • Franciscus Ziekenhuis
      • Sittard-Geleen, Netherlands, 6162 BG
        • Zuyderland ziekenhuis locatie Geleen
      • Venlo, Netherlands, 5912 BL
        • VieCuri - Medisch Centrum voor Noord-Limburg
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 (%)
  • 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)

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trastuzumab
Participants 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).
Drug: Trastuzumab
600 mg SC Q3W by SID
Other Names:
  • Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: From Baseline up to approximately 4 years
From Baseline up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab
Time Frame: Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)
Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)
Health Survey Short Form-36 (SF-36) Score
Time Frame: Cycles 3 and 9 (cycle length=21 days)
Cycles 3 and 9 (cycle length=21 days)
Mood and Anxiety Questionnaire (MASQ) Score
Time Frame: Cycles 3 and 9 (cycle length=21 days)
Cycles 3 and 9 (cycle length=21 days)
Percentage of Participants Choosing to Return to Hospital Administration
Time Frame: Cycle 6 (cycle length=21 days)
Cycle 6 (cycle length=21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2014

Primary Completion (ACTUAL)

September 14, 2018

Study Completion (ACTUAL)

September 14, 2018

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28878
  • 2013-000829-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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