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Trial Title: Treatment Patterns of Neratinib in HER2+ EBC in China

NCT ID: NCT05491057

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Neratinib

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Neratinib
Description: Neratinib standard dose 240 mg once daily for 1 year
Arm group label: Neratinib extended ajuvant treatmeng for 1 year

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

Criteria for eligibility:

Study pop:
Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.

Sampling method: Non-Probability Sample
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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Medical Affair

Address:
City: Shanghai
Country: China

Contact:
Last name: Huanying Zhen, Master

Phone: 010-85347209
Email: nlx-pms@pierre-fabre.com

Contact backup:
Last name: Shujie Pei, Master

Phone: +86-13648686390
Email: Shujie.pei@clinflash.com

Start date: September 30, 2022

Completion date: June 30, 2026

Lead sponsor:
Agency: Pierre Fabre Medicament
Agency class: Industry

Source: Pierre Fabre Medicament

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05491057

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