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

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT01187381
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-14
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-24
• Primary Completion: 2015-10-15
• Study Completion: 2015-10-15
• Status Verified: 2017-05
• Results First Submitted: 2017-05-30
• Results First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Results First Posted: 2017-10-20
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Breast Cancer	Trastuzumab	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.

Primary Outcome Measures

Name	Time	Method
Treatment Duration With Trastuzumab in the Routine Clinical Practice	Baseline up to 5 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation	Baseline up to 5 years
Percentage of Participants Who Had Surgical Procedure for Breast Cancer	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 Previous Neoadjuvant Therapy	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 Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer	Baseline up to 5 years
Progression Free Survival	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	Baseline up to 5 years

Trial Locations

Locations (1)

Cluj Clinical County Hospital; Oncology Dept; 🇷🇴 Cluj-Napoca, Romania