Breast Cancer
Conditions
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).
Interventions
DRUGTrastuzumab
600 mg SC Q3W by SID
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | From Baseline up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Mood and Anxiety Questionnaire (MASQ) Score | Cycles 3 and 9 (cycle length=21 days) |
| Percentage of Participants Choosing to Return to Hospital Administration | Cycle 6 (cycle length=21 days) |
| 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) |
| Health Survey Short Form-36 (SF-36) Score | Cycles 3 and 9 (cycle length=21 days) |
Countries
Netherlands
Outcome results
None listed