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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332981
First received: April 6, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This is an observational follow-up study on the efficacy of 1st-line treatment w ith Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years af ter 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:


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
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 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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01332981     History of Changes
Other Study ID Numbers: ML22958
Study First Received: April 6, 2011
Last Updated: August 4, 2014
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 August 28, 2014