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

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ClinicalTrials.gov Identifier: NCT02040935
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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 chemotherapy (neo-adjuvant or adjuvant).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 21, 2014
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : July 6, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

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 Name: Herceptin




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: From Baseline up to approximately 4 years ]

Secondary Outcome Measures :
  1. 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) ]
  2. Health Survey Short Form-36 (SF-36) Score [ Time Frame: Cycles 3 and 9 (cycle length=21 days) ]
  3. Mood and Anxiety Questionnaire (MASQ) Score [ Time Frame: Cycles 3 and 9 (cycle length=21 days) ]
  4. Percentage of Participants Choosing to Return to Hospital Administration [ Time Frame: Cycle 6 (cycle length=21 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040935


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02040935     History of Changes
Other Study ID Numbers: ML28878
2013-000829-31 ( EudraCT Number )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents