Not provided
Not provided
Not provided
Not provided
Not provided
Study was prematurely terminated because of missing data collection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Duration With Trastuzumab in the Routine Clinical Practice | Baseline up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation | Baseline up to 5 years | |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Female participants with early or metastatic HER2-positive breast cancer
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cluj Clinical County Hospital; Oncology Dept | Cluj-Napoca | 400006 | Romania |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Breast Cancer | Participants with early or metastatic human epidermal growth factor receptor 2 (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
|
| Baseline up to 5 years |
| 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 |
| Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer | Baseline up to 5 years |
| 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 |
| Percentage of Participants by the Site of First Disease Progression | Baseline up to 5 years |
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Duration With Trastuzumab in the Routine Clinical Practice | Number of participant analyzed=participants with data available for this outcome measure. | Posted | Mean | Standard Deviation | Days | Baseline up to 5 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation | All enrolled participants | Posted | Number | percentage of participants | 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. | Number of participants analyzed=participant with data available for this outcome | Posted | Number | percentage of participants | 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). | Number of participants analyzed=participants who were evaluable for this outcome measure | Posted | Number | percentage of participants | Baseline up to 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer | All enrolled participants | Posted | Number | percentage of participants | 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. | Number of participants analyzed=participants who presented progression of disease | Posted | Median | Full Range | days | Baseline uo tp 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants by the Site of First Disease Progression | Number of participants analyzed=participants who presented disease progression | Posted | Number | percentage of participants | Baseline up to 5 years |
|
|
Baseline up to 5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 12 | 250 | 17 | 250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | No Coding Applied | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | No Coding Applied | Non-systematic Assessment |
| |
| Chills | General disorders | No Coding Applied | Non-systematic Assessment |
| |
| Death | General disorders | No Coding Applied | Non-systematic Assessment |
| |
| Metastases to liver | Hepatobiliary disorders | No Coding Applied | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | No Coding Applied | Non-systematic Assessment |
| |
| Hepatitis viral | Hepatobiliary disorders | No Coding Applied | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | No Coding Applied | Non-systematic Assessment |
| |
| Craniofacial fracture | Musculoskeletal and connective tissue disorders | No Coding Applied | Non-systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | No Coding Applied | Non-systematic Assessment |
| |
| Breast cancer metastatic | Reproductive system and breast disorders | No Coding Applied | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | No Coding Applied | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | No Coding Applied | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | No Coding Applied | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | No Coding Applied | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | No Coding Applied | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | No Coding Applied | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | No Coding Applied | Non-systematic Assessment |
| |
| Craniofacial fracture | Musculoskeletal and connective tissue disorders | No Coding Applied | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | No Coding Applied | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | No Coding Applied | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | No Coding Applied | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | No Coding Applied | Non-systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | No Coding Applied | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | No Coding Applied | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | No Coding Applied | Non-systematic Assessment |
| |
| Herpes zoster | Skin and subcutaneous tissue disorders | No Coding Applied | Non-systematic Assessment |
|
Study was prematurely terminated because of missing data collection.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
|
|
|
|
|