Treatment Patterns of Neratinib in HER2+ EBC in China
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPierre Fabre Medicament
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Neratinib
DrugNeratinib standard dose 240 mg once daily for 1 year
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Neratinib extended ajuvant treatmeng for 1 year1 intervention
Trial outcomes
Primary outcomes
1
Duration of Treatment
Median duration of extended adjuvant treatment with neratinib
Time frame
12 months of treatment2
Treatment holds and permanent discontinuations time
Median treatment holds and permanent discontinuations time
Time frame
12 months of treatmentSecondary outcomes
1
Patient demographics
% of patients with different demographic characteristics
Time frame
Baseline2
Patient characteristics
% of patients with different disease characteristics
Time frame
Baseline3
Time to treatment
Median time to treatment since completion of adjuvant regimen
Time frame
Baseline4
Prior adjuvant treatments
% of patients with different prior adjuvant treatments
Time frame
BaselineOther outcomes
1
Time of recurrence
Time from end of neratinib treatment to first invasive recurrence
Time frame
12 months of treatment； 12 months of follow-up2
Recurrent site
% of different site of invasive tumor recurrence
Time frame
12 months of treatment； 12 months of follow-up3
Recurrent size
% of different size of invasive tumor recurrence
Time frame
12 months of treatment； 12 months of follow-up4
QoL - EQ-5D-5L
Median score of the EQ-5D-5L during neratinib treatment. EQ-5D-5L scale as self-reported health-related quality of life.
Time frame
12 months of treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: