Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab [herceptin]
Phase phase 3
Target HER2
Sponsor Hoffmann-La Roche
Start date November 2013
End date September 2017
Trial size 102 participants
Trial identifier NCT01926886, 2013-000123-13, ML28794

Summary

This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of Herceptin (trastuzumab) in patients with HER2-positive early breast cancer. Patients who have completed the first 6 cycles of intravenous Herceptin as part of the (neo)adjuvant treatment will be eligible to receive a further 12 cycles of Herceptin in this study. For the first 3 cycles, Herceptin will be administered intravenously (6 mg/kg) at the hospital. The next 3 cycles, Herceptin (600 mg every 3 weeks) will be administered subcutaneously via a hand-held syringe by a trained HCP at the hospital, and for the last 6 cycles Herceptin will be administered subcutaneously via a hand-held syringe by a trained HCP at the patient's home.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
trastuzumab [herceptin]
6 mg/kg intravenously (IV) every 3 weeks, 3 cycles
trastuzumab [herceptin]
600 mg subcutaneously every 3 weeks, administered via a hand-held syringe by a trained HCP at the hospital, 3 cycles
trastuzumab [herceptin]
600 mg/kg subcutaneously every 3 weeks, administered via a hand-held syringe by a HCP at the patient's home, 6 cycles

Primary Outcomes

Measure
Safety: Incidence of adverse events
time frame: 32 months

Secondary Outcomes

Measure
Patient reported outcomes: Patient satisfaction questionnaire (PSQ1/PSQ2), MD Anderson Symptom Inventory (MDASI)
time frame: 8 months
HCP-reported outcomes: Health Care Professional Questionnaire (HCPEX-1)
time frame: 9 weeks
Patient experience questionnaires (PEX-P1/PEX-P2)
time frame: 8 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Female and male patients, >/= 18 years of age - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast - HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Hormonal therapy will be allowed as per institutional guidelines - Left ventricular ejection fraction (LVEF) of >/= 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrolment - Patients have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment - No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, (neo-adjuvant or adjuvant) - Use of concurrent curative radiotherapy will be permitted Exclusion Criteria: - History of other malignancy which could 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 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 - 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 - Women of childbearing potential and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment - Concurrent enrolment in another clinical trial using an investigational anti-cancer 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 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 bone marrow, hepatic or renal function

Additional Information

Official title A Single Arm Multi-center Study Investigating the at Home Administration of Trastuzumab Subcutaneous Vial for the Treatment of Patients With HER2-positive Early Breast Cancer.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.