- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424473
Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer
February 21, 2020 updated by: Seagen Inc.
Physicians interested in requesting a single patient IND should contact Seattle Genetics' Medical Information (medinfo@seagen.com).
Study Overview
Status
No longer available
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
-
Exclusion Criteria:
-
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?
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 Registration Dates
First Submitted
January 31, 2018
First Submitted That Met QC Criteria
January 31, 2018
First Posted (ACTUAL)
February 7, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
- Breast Cancer
- Neoplasms
- Breast Carcinoma
- Metastatic Breast Cancer
- Breast Neoplasms
- tucatinib
- Neoplasms by Site
- Breast Diseases
- Recurrent Breast Carcinoma
- Stage IV Breast Cancer
- ONT-380
- HER-2 Positive Breast Cancer
- ARRY-380
- HER2 Positive Breast Carcinoma
- HER2 Positive Locally Advanced Breast Cancer
- HER-2 Positive Locally Advanced Breast Cancer
- Metastatic Malignant Neoplasm in the Brain
- Brain Metastases in Breast Cancer
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONT-380-014
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 Tucatinib
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Cascadian Therapeutics Inc.Completed
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Seagen Inc.RecruitingHER2-positive Breast CancerUnited States, Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom
-
UNICANCERSeagen Inc.RecruitingHER2-positive Metastatic Breast Cancer | Leptomeningeal Disease | Leptomeningeal MetastasisFrance
-
Seagen Inc.CompletedHER2 Positive Breast CancersUnited States, Canada
-
Seagen Inc.Active, not recruitingGastric Adenocarcinoma | Esophageal Adenocarcinoma | Gastroesophageal Junction AdenocarcinomaUnited States, Korea, Republic of, United Kingdom, Taiwan, Canada, Australia
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Institut CurieSeagen Inc.RecruitingHER2-positive Breast CancerFrance
-
Baptist Health South FloridaSeagen Inc.RecruitingHER2-positive Breast Cancer | Brain MetastasesUnited States
-
Seagen Inc.Completed
-
Silverback TherapeuticsTerminatedHER2-positive Breast Cancer | HER2-positive Gastric Cancer | HER2-positive Colorectal Cancer | HER2-expressing Non-small Cell Lung CancerUnited States
-
Seagen Inc.CompletedHepatic ImpairmentUnited States