Breast Cancer
Conditions
Brief summary
This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.
Interventions
DRUGTrastuzumab
Trastuzumab will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy).
DRUGDoxorubicin
Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion.
DRUGCyclophosphamide
Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion.
DRUGPaclitaxel
Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
DRUGDocetaxel
Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
DRUGCarboplatin
Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion.
Neo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names.
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
* 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 participants in the neo-adjuvant setting * Left ventricular ejection fraction (LVEF) of greater than or equal to (\>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab, 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 enrollment * HER2-positive disease immunohistochemistry 3 plus (IHC3+) 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) * 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. 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 at least 5 years, are eligible * Severe dyspnea at rest or requirement for supplementary oxygen therapy * 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 * Concurrent enrollment 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, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma * Inadequate bone marrow, hepatic or renal function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant Satisfaction Questionnaire Score | Week 52 |
| Percentage of Participants with Adverse Events (AEs) | Baseline up to 4.5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) | Baseline until first documented disease or death, whichever comes first (up to 4.5 years) | Diagnosis of breast cancer relapse will be made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence include radiology, computed tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainty, disease relapse should be confirmed by histological or cytological examination of a suspicious lesion, if possible. |
| Number of Days on Trastuzumab Treatment | Baseline up to 1 year | — |
| Healthcare Professional Experience and Satisfaction Questionnaire Score | Week 52 | — |
| Cumulative Dose of Trastuzumab | Baseline up to 1 year | — |
| Duration of Treatment, Follow-up, and Safety Observation | Baseline up to 4.5 years | — |
| Total Daily Dose of Trastuzumab | Baseline up to 1 year | — |
| Overall Survival (OS) | Baseline until death from any cause (up to 4.5 years) | — |
Countries
Algeria, Morocco, Saudi Arabia, Tunisia, Turkey (Türkiye)
Outcome results
None listed