An Observational Follow-up Study of 1st-Line Treatment With Herceptin (Trastuzumab) in Patients With Metastatic Breast Cancer (Post-HERMINE)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 6, 2011
Last updated: November 2, 2015
Last verified: November 2015
This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Overall Survival Estimation After a 7 Year Follow-up in Metastatic Breast Cancer Patients Treated by Herceptin® as 1st Line Therapy (Post-HERMINE Study)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Duration of treatment [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Correlation of clinical factors (treatment duration/exposure, first progression, cerebral metastases) and overall survival/time to progression [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
metastatic breast cancer patients treated by Herceptin® as 1st line therapy

Inclusion Criteria:

  • Female patient, >/= 18 years of age
  • Metastatic breast cancer
  • 1st-line treatment with Herceptin initiated in 2002
  • Included in pharmaco-epidemiologic HERMINE study

Exclusion Criteria:

  • Patient died before scheduled follow-up visit (March 2005)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01332981

Neuilly-sur-seine, France, 92521
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01332981     History of Changes
Other Study ID Numbers: ML22958 
Study First Received: April 6, 2011
Last Updated: November 2, 2015
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on February 11, 2016