Breast Cancer
Conditions
Brief summary
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
Interventions
DRUGNeratinib
Neratinib standard dose 240 mg once daily for 1 year
Sponsors
Pierre Fabre Medicament
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent approved by the reviewing Ethics Committee (EC). * Adult patients (≥18 years of age, no upper limit). * Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.
Exclusion criteria
* Presence of any contraindication with regard to the neratinib treatment. * Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Treatment | 12 months of treatment | Median duration of extended adjuvant treatment with neratinib |
| Treatment holds and permanent discontinuations time | 12 months of treatment | Median treatment holds and permanent discontinuations time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose adjustments | 12 months of treatment | % of patients with dose adjustments |
| Concomitant medication | 12 months of treatment | % of patients with different concomitant medications |
| Incidence of AESI | 12 months of treatment | Incidence of all grades of adverse events of special interest (AESI) |
| Type of AESI | 12 months of treatment | % of different type of all grades of adverse events of special interest (AESI) |
| Severity of AESI | 12 months of treatment | % of patients with adverse events by severity |
| action taken for AESI | 12 months of treatment | % of patients with action taken against adverse events |
| Patient demographics | Baseline | % of patients with different demographic characteristics |
| Patient characteristics | Baseline | % of patients with different disease characteristics |
| Time to treatment | Baseline | Median time to treatment since completion of adjuvant regimen |
| Prior adjuvant treatments | Baseline | % of patients with different prior adjuvant treatments |
| Dose intensity | 12 months of treatment | Absolute and relative dose intensity |
Other
| Measure | Time frame | Description |
|---|---|---|
| QoL - EQ-5D-5L | 12 months of treatment | Median score of the EQ-5D-5L during neratinib treatment. EQ-5D-5L scale as self-reported health-related quality of life. |
| QoL - FACIT D | 12 months of treatment | Median score of the FACIT D during neratinib treatment. FACIT D scale as self-reported health-related quality of life. |
| Recurrent site | 12 months of treatment； 12 months of follow-up | % of different site of invasive tumor recurrence |
| Time of recurrence | 12 months of treatment； 12 months of follow-up | Time from end of neratinib treatment to first invasive recurrence |
| Recurrent size | 12 months of treatment； 12 months of follow-up | % of different size of invasive tumor recurrence |
Countries
China
Contacts
Primary ContactHuanying Zhen, Master
Backup ContactShujie Pei, Master
Outcome results
None listed