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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01187381

Acronym

HERODOT

Enrollment

250

Registered

2010-08-24

Start date

2010-04-14

Completion date

2015-10-15

Last updated

2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGTrastuzumab

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Treatment Duration With Trastuzumab in the Routine Clinical Practice	Baseline up to 5 years

Secondary

Measure	Time frame	Description
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 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 Discontinued Trastuzumab Therapy According to Reasons for Discontinuation	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	—
Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer	Baseline up to 5 years	—

Countries

Romania

Participant flow

Participants by arm

Arm	Count
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, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.	250
Total	250

Arm

Count

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, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.

250

Total

250

Baseline characteristics

Characteristic	Participants With Breast Cancer
Age, Continuous	51.2600 years STANDARD_DEVIATION 10.61939
Sex: Female, Male Female	250 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	17 / 250
serious Total, serious adverse events	12 / 250