Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment trastuzumab [herceptin]
Phase phase 3
Target HER2
Sponsor Hoffmann-La Roche
Start date February 2014
End date July 2018
Trial size 125 participants
Trial identifier NCT02040935, 2013-000829-31, ML28878

Summary

This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of Herceptin (trastuzumab) administered subcutaneously by a single-use injection device (SID) in patients with HER2-positive early breast cancer. Following surgery (and neo-adjuvant or adjuvant chemotherapy), patients will receive Herceptin 600 mg subcutaneously by SID every 3 weeks for a total of 1 year, unless disease recurrence or unacceptable toxicity occurs. After the first 3 cycles, patients will be permitted to self-administer Herceptin under supervision of a HCP.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
trastuzumab [herceptin]
600 mg subcutaneously every 3 weeks by single-use injection device

Primary Outcomes

Measure
Safety: Incidence and severity of adverse events and serious adverse events by NCI CTAE version 4-0
time frame: approximately 1 year

Secondary Outcomes

Measure
Pharmacokinetics: Trough concentrations (Ctrough) of trastuzumab following in-hospital and in-home administration via SID
time frame: Pre-dose Cycles 2, 3, 9, and 10 or 13 (Weeks 4, 7, 25, and 28 or 32)
Patient reported health/mental status assessed by questionnaire (SF-36 and MASQ)
time frame: 28 weeks

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 - 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 except for early breast cancer patients in the neo-adjuvant setting - Left ventricular ejection fraction >/= 55% - 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) for early breast cancer Exclusion Criteria: - History of other malignancy, except for 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 the last 5 years - Patients with severe dyspnea at rest or requiring supplementary oxygen therapy - Patients 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 ECG, poorly controlled hypertension - Pregnant or lactating women - Women of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment - Concurrent enrolment 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 bone marrow, hepatic or renal function

Additional Information

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