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

Breast Cancer Clinical Trial

— HOMERUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040935
• Other study ID #: ML28878
• Secondary ID: 2013-000829-31
• Status: Completed
• Phase: Phase 3
• Start date: February 21, 2014
• Est. completion date: September 14, 2018

Study information

• Verified date: August 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 chemotherapy (neo-adjuvant or adjuvant).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab
600 mg SC Q3W by SID

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Meander Medisch Centrum; Locatie Lichtenberg	Amersfoort
Netherlands	Amphia ziekenhuis, locatie langendijk	Breda
Netherlands	IJsselland Ziekenhuis	Capelle Aan De Yssel
Netherlands	Reinier de Graaf Gasthuis; Oncology	Delft
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde	EDE
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Kennemer Gasthuis	Haarlem
Netherlands	Ziekenhuisgroep Twente, Hengelo	Hengelo
Netherlands	Tergooiziekenhuizen, loc. Hilversum	Hilversum
Netherlands	Spaarne Ziekenhuis Haarlem; Oncologie	Hoofddorp
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Netherlands	Franciscus Ziekenhuis	Roosendaal
Netherlands	Zuyderland ziekenhuis locatie Geleen	Sittard-Geleen
Netherlands	VieCuri - Medisch Centrum voor Noord-Limburg	Venlo
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)		From Baseline up to approximately 4 years
Secondary	Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab		Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)
Secondary	Health Survey Short Form-36 (SF-36) Score		Cycles 3 and 9 (cycle length=21 days)
Secondary	Mood and Anxiety Questionnaire (MASQ) Score		Cycles 3 and 9 (cycle length=21 days)
Secondary	Percentage of Participants Choosing to Return to Hospital Administration		Cycle 6 (cycle length=21 days)