Trial Information
A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive
Inclusion Criteria:
- Female patients, >/= 18 years of age
- HER2-positive metastatic breast cancer or locally advanced breast cancer
- Systemic treatment included Herceptin as 1st line therapy
- Without progression for at least 3 years after the beginning of Herceptin treatment
- Alive or not alive and treated or not treated with Herceptin at the time of inclusion
Exclusion Criteria:
- Disease progression <3 years after beginning 1st-line therapy with Herceptin
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Tumor hormone receptor status (HER2/HR) of patients without progression for at least 3 years after the beginning of 1st line Herceptin treatment
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Commission Nationale de l'Informatique et des Libertés (CNIL)
Study ID:
ML23001
NCT ID:
NCT01480674
Start Date:
March 2011
Completion Date:
November 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms