Treatment Patterns of Neratinib in HER2+ EBC in China
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Neratinib extended ajuvant treatmeng for 1 year
|
Drug: Neratinib
Neratinib standard dose 240 mg once daily for 1 year
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 adjustments [12 months of treatment]
% of patients with dose adjustments
- Dose intensity [12 months of treatment]
Absolute and relative dose intensity
- 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
Other Outcome Measures
- Time of recurrence [12 months of treatment； 12 months of follow-up]
Time from end of neratinib treatment to first invasive recurrence
- Recurrent site [12 months of treatment； 12 months of follow-up]
% of different site of invasive tumor recurrence
- Recurrent size [12 months of treatment； 12 months of follow-up]
% of different size of invasive tumor recurrence
- 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.
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Affair | Shanghai | China |
Sponsors and Collaborators
- Pierre Fabre Medicament
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PF008