Clinical trial NCT02040935: A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: From Baseline up to approximately 4 years
Secondary outcomes:
measure: Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab
timeFrame: Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)
measure: Health Survey Short Form-36 (SF-36) Score
timeFrame: Cycles 3 and 9 (cycle length=21 days)
measure: Mood and Anxiety Questionnaire (MASQ) Score
timeFrame: Cycles 3 and 9 (cycle length=21 days)
measure: Percentage of Participants Choosing to Return to Hospital Administration
timeFrame: Cycle 6 (cycle length=21 days)
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum; Locatie Lichtenberg
city: Breda
country: Netherlands
facility: Amphia ziekenhuis, locatie langendijk
city: Capelle Aan De Yssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis; Oncology
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: EDE
country: Netherlands
facility: Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente, Hengelo
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen, loc. Hilversum
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis Haarlem; Oncologie
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Roosendaal
country: Netherlands
facility: Franciscus Ziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland ziekenhuis locatie Geleen
city: Venlo
country: Netherlands
facility: VieCuri - Medisch Centrum voor Noord-Limburg
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: