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

Breast Cancer Clinical Trial

— HERODOT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01187381
• Other study ID #: ML25235
• Status: Terminated
• Phase: N/A
• First received: August 20, 2010
• Last updated: May 30, 2017
• Start date: April 14, 2010
• Est. completion date: October 15, 2015

Study information

• Verified date: May 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer. Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols. Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: October 15, 2015
• Est. primary completion date: October 15, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HER2-positive breast cancer

• Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols

• Written informed consent to data collection

Exclusion Criteria:

• Any contraindication to trastuzumab

• Clinically relevant cardiovascular disorder or disease

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab
Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines

Locations

Country	Name	City	State
Romania	Cluj Clinical County Hospital; Oncology Dept	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Duration With Trastuzumab in the Routine Clinical Practice		Baseline up to 5 years
Secondary	Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation		Baseline up to 5 years
Secondary	Percentage of Participants Who Received Previous Neoadjuvant Therapy	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.	Baseline up to 5 years
Secondary	Percentage of Participants Who Had Surgical Procedure for Breast Cancer	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).	Baseline up to 5 years
Secondary	Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer		Baseline up to 5 years
Secondary	Progression Free Survival	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.	Baseline uo tp 5 years
Secondary	Percentage of Participants by the Site of First Disease Progression		Baseline up to 5 years