Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab iv, trastuzumab sc vial, trastuzumab sid
Phase phase 3
Target HER2
Sponsor Hoffmann-La Roche
Start date July 2014
End date June 2018
Trial size 90 participants
Trial identifier NCT02194166, ML28839

Summary

This multicenter study in patients with HER2-positive eBC will investigate patients' pain and discomfort of subcutaneous (SC) trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, patients wil obtain at least 18 cycles/1 year of trastuzumab (4 cycles of IV and 14 cycles of SC trastuzumab).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
7 cycles with SC vial formulation followed by 7 cycles of SID administration
trastuzumab sc vial
Fixed dose 600 mg SC trastuzumab assisted administration in hospital setting
trastuzumab sid
Fixed dose 600 mg SC trastuzumab using SID, self-administration after initial injection and instructions by HCP in hospital setting
(Experimental)
7 cycles of SID followed by 7 cycles of SC vial formulation administration
trastuzumab sc vial
Fixed dose 600 mg SC trastuzumab assisted administration in hospital setting
trastuzumab sid
Fixed dose 600 mg SC trastuzumab using SID, self-administration after initial injection and instructions by HCP in hospital setting
(Experimental)
All patients, first 4 cycles
trastuzumab iv
Loading dose 8 mg/kg at Day 1 Cycle 1, followed by 6 mg/kg trastuzumab administered intraveneously (IV) every 3 weeks

Primary Outcomes

Measure
Patient pain, as measured on a 10 cm Visual Analogue Scale
time frame: Every treatment cycle, assessed up to 4 years
Patient discomfort, as measured on a 10 cm Visual Analogue Scale
time frame: Every treatment cycle, assessed up to 4 years

Secondary Outcomes

Measure
Healthcare professional satisfaction with SC formulation, assessed by Health Care Professional Questionnaire (HCPQ)
time frame: Week 22
Patient satisfaction with SC formulation, assessed by Patients Satisfaction Questionnaire (PSQ)
time frame: Week 52 (Cycle 18)
Healthcare professional perceived time savings with SC trastuzumab, assessed by HCPQ
time frame: Week 22
Incidence of adverse events
time frame: Up to 4 years
Overall survival
time frame: From first study treatment to death from any cause, assessed up to 4 years
Disease-free survival
time frame: From first study treatment to documented disease progression or death, assessed up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Female and male patients aged >/= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Hormonal therapy allowed as per institutional guidelines - Left ventricular ejection fraction (LVEF) of >/= 55% measured by echocardiography (ECHO) prior to first dose of trastuzumab - HER2-positive disease immunohistochemistry (IHC) 3+ or in-situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast - No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) - Patients who have completed all (neo)adjuvant treatment or patients after adjuvant chemotherapy with doxorubicin and cyclophosphamide (AC) to whom the 4 subsequent cycles of Herceptin in combination with paclitaxel or docetaxel are indicated per local practice - Not more than 3 months should have elapsed since the last dose of adjuvant chemotherapy in case of subsequent treatment scheme Exclusion Criteria: - Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent - History of other malignancy that can affect compliance with the protocol or interpretation of results. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible. Patients with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study - Patients with severe dyspnea at rest or requiring supplementary oxygen therapy - Patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness - Prior maximum cumulative dose of doxorubicin >360 mg/m2 or maximum cumulative dose of epirubicin >720 mg/m2 or equivalent - Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension - Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) - Pregnant or lactating women - Concurrent enrollment in another clinical trial using an investigational anticancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment - Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin®, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma - Inadequate bone marrow, hepatic, or renal function - Major surgical procedure or significant traumatic injury within 14 days prior to the first dose of study treatment or anticipated need for major surgery during the course of study treatment

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.