An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer

Roche

Status: Completed

Conditions: Gastric Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01220934

ML22834

Details and patient eligibility

About

This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.

Enrollment: 443 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/=18 years of age
• Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) with locally advanced and/or metastatic disease
• HER2-positive tumor
• Patients who are eligible for treatment with Herceptin according to the judgment of the physician

Exclusion criteria

• Unwilling or unable to sign informed consent form
• Any contraindications, interactions and incompatibilities to Herceptin

Trial design

443 participants in 1 patient group

Cohort