An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (HERODOT)
|ClinicalTrials.gov Identifier: NCT01187381|
Recruitment Status : Terminated (Study was prematurely terminated because of missing data collection.)
First Posted : August 24, 2010
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Trastuzumab|
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Multicenter, Single-Arm, Observational Study of Mean Duration of Trastuzumab (Herceptin) Treatment in Patients With HER2-Positive Early or Metastatic Breast Cancer in Romanian Population|
|Actual Study Start Date :||April 14, 2010|
|Primary Completion Date :||October 15, 2015|
|Study Completion Date :||October 15, 2015|
Participants with Breast Cancer
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, will be observed. Dosing and treatment duration of the trastuzumab will be at the discretion of the treating physician.
Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines
Other Name: Herceptin
- Treatment Duration With Trastuzumab in the Routine Clinical Practice [ Time Frame: Baseline up to 5 years ]
- Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation [ Time Frame: Baseline up to 5 years ]
- Percentage of Participants Who Received Previous Neoadjuvant Therapy [ Time Frame: Baseline up to 5 years ]As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies. Percentage of participants who received these therapies is reported.
- Percentage of Participants Who Had Surgical Procedure for Breast Cancer [ Time Frame: Baseline up to 5 years ]Percentage of participants who underwent different types of surgical procedures for breast cancer are reported. Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).
- Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer [ Time Frame: Baseline up to 5 years ]
- Progression Free Survival [ Time Frame: Baseline uo tp 5 years ]Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician. Due to observational nature of the study, there was no specific method of assessment used to define progressive disease. Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.
- Percentage of Participants by the Site of First Disease Progression [ Time Frame: Baseline up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187381
|Cluj Clinical County Hospital; Oncology Dept|
|Cluj-Napoca, Romania, 400006|
|Study Director:||Clinical Trials||Hoffmann-La Roche|