Last updated: October 25, 2020
Sponsor: Yonsei University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Neoplasm Metastasis
Breast Cancer
Treatment
N/AClinical Study ID
NCT03617341
4-2018-0254
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients over 19 years
- Pathologically documented breast cancer that:
- is unresectable or metastatic ;
- has confirmed HER2 positive expression according to American Society of ClinicalOncology- College of American Pathologists (ASCO-CAP) guidelines or triplenegative breast cancer
- No prior systemic palliative treatment of metastatic breast cancer
- Must have provided informed consent for study participation before performance of anystudy-specific procedures or tests
Exclusion
Exclusion Criteria:
- History of prior treatments about brain metastases or leptomeningeal metastases
- Symptomatic brain metastases at screening period
- Has received more than second-line systemic treatments (including endocrine therapy)
- For subjects who have difficulty lying down or who have claustrophobia, they canundergo sedation during brain MRI
- History of hypersensitivity reaction to contrast or drug allergic reaction
- Patients who inserted metallic prosthesis (pacemaker, denture, hearing aid, aneurysmclip, metallic material of eyeball, artificial joint, insulin pump, chemo-port,temporary tissue expander for breast reconstruction, etc) can be conducted afterconsultation with investigator before MRI.
- Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.
- Social, familial, or geographical factors that would interfere with studyparticipation or follow-up
Study Design
Total Participants: 200
Study Start date:
October 02, 2018
Estimated Completion Date:
June 03, 2023
Study Description
Connect with a study center
Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting

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