- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443467
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer
November 1, 2016 updated by: Hoffmann-La Roche
This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
211
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sremska Kamenica, Serbia, 21204
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Participants with HER2-positive early breast cancer
Description
Inclusion Criteria:
- Female patients > or = 18 years of age
- Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression
- Previously treated with adjuvant antracycline containing chemotherapy
- Left Ventricular Ejection Fraction (LVEF) > 50%
- Eastern Cooperative Oncology Group (ECOG) score < or = 2
- Life expectancy > or = 12 weeks
Exclusion Criteria:
- Left Ventricular Ejection Fraction (LVEF) < 50%
- Advanced pulmonary disease
- Severe dyspnea
- Abnormal laboratory results within 14 days prior to registration
- Peripheral neuropathy
- Presence of Central Nervous System (CNS) metastasis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HER2-positive early breast cancer
Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants with adverse events
Time Frame: Up to 3 years
|
Up to 3 years
|
Percentage of participants with serious adverse events
Time Frame: Up to 3 years
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (ACTUAL)
November 1, 2009
Study Completion (ACTUAL)
November 1, 2009
Study Registration Dates
First Submitted
May 11, 2015
First Submitted That Met QC Criteria
May 12, 2015
First Posted (ESTIMATE)
May 13, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML20397
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer, Early Breast Cancer
-
University Hospital TuebingenRecruitingAdvanced/Metastatic Breast Cancer | Breast Cancer (Early Breast Cancer)Germany
-
AstraZenecaRecruitingBreast Cancer, Early Breast CancerUnited States, Canada, United Kingdom, China, Argentina, Australia, Hungary, Netherlands, Korea, Republic of, France, Germany, Italy, Belgium, Bulgaria, India, Mexico, Spain, Vietnam, Colombia, Japan, Peru, Brazil, Malaysia, Taiwan, Tha... and more
-
Stanford UniversityTerminatedBreast Cancer | Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Breast Cancer Metastatic Breast CancerUnited States
-
MedSIRAstraZeneca; Daiichi Sankyo, Inc.CompletedMetastatic Breast Cancer | Early Breast Cancer | Locally Advanced Breast CancerSpain
-
Stanford UniversityNational Institutes of Health (NIH); University of California; Breast Cancer... and other collaboratorsActive, not recruitingBreast Cancer | Breast Cancer Non-invasive Breast Cancer | Breast Cancer Early Stage Breast Cancer (Stage 1-3)United States
-
Intuitive SurgicalRecruitingBreast Cancer | Breast Cancer Female | Breast | Breast Disease | Breast Cancer, Early-OnsetUnited States
-
Tanvex BioPharma USA, Inc.CompletedBreast Cancer | Breast Neoplasms | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Early-stage Breast CancerBelarus, Chile, Georgia, Hungary, India, Mexico, Peru, Philippines, Russian Federation, Ukraine
-
Wake Forest University Health SciencesAtrium Health NavicentActive, not recruitingBreast Cancer Female | Early-stage Breast CancerUnited States
-
Universitair Ziekenhuis BrusseleTheRNA immunotherapiesRecruitingBreast Cancer Female | Early-stage Breast CancerBelgium
-
Dana-Farber Cancer InstituteCompletedEarly Stage Breast Cancer | Breast Cancer Stage I | Breast Cancer Stage IIUnited States
Clinical Trials on No intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States