Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neratinib extended ajuvant treatmeng for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neratinib | Drug | Neratinib standard dose 240 mg once daily for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Treatment | Median duration of extended adjuvant treatment with neratinib | 12 months of treatment |
| Treatment holds and permanent discontinuations time | Median treatment holds and permanent discontinuations time | 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | % of patients with different demographic characteristics | Baseline |
| Patient characteristics | % of patients with different disease characteristics |
| Measure | Description | Time Frame |
|---|---|---|
| Time of recurrence | Time from end of neratinib treatment to first invasive recurrence | 12 months of treatment； 12 months of follow-up |
| Recurrent site | % of different site of invasive tumor recurrence |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huanying Zhen, Master | Contact | +86010-8534-7209 | nlx-pms@pierre-fabre.com | |
| Shujie Pei, Master | Contact | +86-13648686390 | shujie.pei@clinflash.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affair | Shanghai | China |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C487932 | neratinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline |
| Time to treatment | Median time to treatment since completion of adjuvant regimen | Baseline |
| Prior adjuvant treatments | % of patients with different prior adjuvant treatments | Baseline |
| Dose adjustments | % of patients with dose adjustments | 12 months of treatment |
| Dose intensity | Absolute and relative dose intensity | 12 months of treatment |
| Concomitant medication | % of patients with different concomitant medications | 12 months of treatment |
| Incidence of AESI | Incidence of all grades of adverse events of special interest (AESI) | 12 months of treatment |
| Type of AESI | % of different type of all grades of adverse events of special interest (AESI) | 12 months of treatment |
| Severity of AESI | % of patients with adverse events by severity | 12 months of treatment |
| action taken for AESI | % of patients with action taken against adverse events | 12 months of treatment |
| 12 months of treatment； 12 months of follow-up |
| Recurrent size | % of different size of invasive tumor recurrence | 12 months of treatment； 12 months of follow-up |
| 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. | 12 months of treatment |
| QoL - FACIT D | Median score of the FACIT D during neratinib treatment. FACIT D scale as self-reported health-related quality of life. | 12 months of treatment |
| D017437 |
| Skin and Connective Tissue Diseases |