The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer). This study is seeking participants who: * have breast cancer that is hard to treat and has spread in the body (advanced cancer) * have tumors that have HER2 on them * have received previous treatment for their advanced breast cancer All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein). Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks. The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Given into the vein (IV; intravenous) every 2 weeks.
Southern Cancer Center, PC
Daphne, Alabama, United States
RECRUITINGSouthern Cancer Center, PC
Foley, Alabama, United States
RECRUITINGSouthern Cancer Center, PC
Mobile, Alabama, United States
RECRUITINGBanner Gateway Medical Center
Gilbert, Arizona, United States
Objective response (OR) by investigator assessment
The primary endpoint OR by investigator assessment is defined as the proportion of participants with confirmed CR or PR as determined by investigator per RECIST Version 1.1.
Time frame: From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years
Duration of response (DOR) per RECIST v1.1 by investigator assessment
DOR by investigator assessment is defined as the time from first documentation of objective response (CR or PR) by investigator assessment per RECIST version 1.1 that is subsequently confirmed, to the first documentation of progressive disease or to death due to any cause, whichever comes first.
Time frame: From first documentation of objective response (CR or PR) by investigator assessment per RECIST version 1.1 that is subsequently confirmed, to the first documentation of progressive disease or to death due to any cause; up to approximately 2 years
Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment
DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1.
Time frame: From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
PFS by investigator assessment is defined as the time from C1D1 to the first documentation of disease progression as determined by investigator per RECIST version 1.1, or to death due to any cause, whichever comes first.
Time frame: From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; ; up to approximately 2 years
Overall survival (OS)
OS is defined as the time from C1D1 to date of death due to any cause.
Time frame: From Cycle 1 Day 1 until death due to any cause; up to approximately 3 years
PK Parameter: Serum Concentrations of disitamab vedotin, total antibody, and unconjugated MMAE
The Antibody-drug conjugate (TAb), and unconjugated Monomethyl auristatin E (MMAE) concentrations for disitamab vedotin summarized at each PK sampling time point.
Time frame: From Cycle 1 Day 1 to end of treatment; up to approximately 2 years
Incidence of anti-drug antibodies (ADA) against disitamab vedotin
The percentage of participants with positive ADA will be summarized.
Time frame: From Cycle 1 Day 1 to end of treatment; up to approximately 2 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Type, incidence, severity, seriousness, and relatedness of AEs. Type, incidence, and severity of laboratory abnormalities and significant changes from baseline.
Time frame: Up to approximately 2 years
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
NOT_YET_RECRUITINGLos Angeles Cancer Network - Anaheim
Anaheim, California, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
NOT_YET_RECRUITINGLos Angeles Cancer Network
Fountain Valley, California, United States
RECRUITINGLos Angeles Hematology Oncology Medical Group
Glendale, California, United States
RECRUITINGCity of Hope at Irvine Lennar
Irvine, California, United States
NOT_YET_RECRUITING...and 156 more locations