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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.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332981
First received: April 6, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

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)

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332981

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

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01332981     History of Changes
Other Study ID Numbers: ML22958
Study First Received: April 6, 2011
Last Updated: November 22, 2011
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013