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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 28, 2010
Last updated: April 7, 2014
Last verified: April 2014

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.

Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Documentation of the testing process for HER2-positive tumors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Documentation of backbone chemotherapy treatment and concomitant medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Surveillance of pain intensity and analgesic consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Surveillance of weight change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 443
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Gastric cancer patients receiving Herceptin in routine clinical practice


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01220934

Frankfurt, Germany, 60488
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01220934     History of Changes
Other Study ID Numbers: ML22834
Study First Received: September 28, 2010
Last Updated: April 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 21, 2014