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
|ClinicalTrials.gov Identifier: NCT01480674|
Recruitment Status : Completed
First Posted : November 29, 2011
Results First Posted : February 24, 2016
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Trastuzumab|
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||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|
|Actual Study Start Date :||March 28, 2011|
|Primary Completion Date :||November 16, 2012|
|Study Completion Date :||November 16, 2012|
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.
- Tumor Hormone Receptor Status of Participants Without Progression [ Time Frame: Up to 3 years ]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 ]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
- Progression-free Survival [ Time Frame: Up to 12 years ]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 ]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 ]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 ]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 ]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 ]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 ]Total treatment duration and duration of the first line of treatment is reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480674
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|Study Director:||Clinical Trials||Hoffmann-La Roche|