An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01480674
First received: August 18, 2011
Last updated: October 6, 2014
Last verified: October 2014

August 18, 2011
October 6, 2014
March 2011
November 2012   (final data collection date for primary 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Prevalence of bone metastases in patients without progression for at least 3 years after the beginning of 1st line Herceptin treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical/tumour characteristics (HER2/HR status) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01480674 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Dosage schedule/duration of Herceptin treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Antineoplastic treatment (drugs, dosage schedule, duration) in combination with and after discontinuation of Herceptin treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years
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

This observational study will characterize retrospectively patients with HER2-po sitive metastatic or locally advanced breast cancer who had received treatment w ith Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:

unknown

Probability Sample

Patients with HER2-positive metastatic breast cancer or locally advanced breast cancer whose systemic treatment included Herceptin as 1st line therapy, and who were without progression for at least 3 years after beginning Herceptin

Breast Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01480674
ML23001
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP