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: June 6, 2016
Last verified: June 2016

August 18, 2011
June 6, 2016
March 2011
November 2012   (final data collection date for primary outcome measure)
  • Tumor Hormone Receptor Status of Participants Without Progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.
  • Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported
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: Up to 12 years ] [ Designated as safety issue: No ]
    The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.
  • Time to Progression [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.
  • Overall Survival [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.
  • Dosage Schedule of Herceptin Treatment [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.
  • Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.
  • Number of Participants With Any Adverse Events and Serious Adverse Events [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.
  • The Duration of Treatment of Trastuzumab [ Time Frame: Up to 1 Year ] [ Designated as safety issue: No ]
    Total treatment duration and duration of the first line of treatment is reported.
  • 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 ]
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-positive metastatic or locally advanced breast cancer who had received treatment with 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
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
Drug: Trastuzumab
Trastuzumab
Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Intervention: Drug: Trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01480674
ML23001
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2016

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