A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
- Conditions
- Breast CancerBreast Neoplasms
- Interventions
- Registration Number
- NCT06966453
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1: HER2+ locally advanced or metastatic breast cancer Disitamab vedotin disitamab vedotin monotherapy Cohort 2: HR+, HER2-low locally advanced or metastatic breast cancer Disitamab vedotin disitamab vedotin monotherapy Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low locally advanced or metastatic breast cancer Disitamab vedotin disitamab vedotin monotherapy
- Primary Outcome Measures
Name Time Method Objective response (OR) by investigator assessment 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 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.
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) per RECIST v1.1 by investigator assessment 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 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.
Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment 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 DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or SD by investigator assessment per RECIST version 1.1.
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment 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 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.
Overall survival (OS) From Cycle 1 Day 1 until death due to any cause; up to approximately 3 years OS is defined as the time from C1D1 to date of death due to any cause.
PK Parameter: Serum Concentrations of disitamab vedotin, total antibody, and unconjugated MMAE From Cycle 1 Day 1 to end of treatment; up to approximately 2 years Antibody-drug conjugate, TAb, and unconjugated MMAE concentrations for disitamab vedotin summarized at each PK sampling time point.
Incidence of anti-drug antibodies (ADA) against disitamab vedotin From Cycle 1 Day 1 to end of treatment; up to approximately 2 years The percentage of participants with positive ADA will be summarized.
Incidence of Adverse Events and Serious Adverse Events Up to approximately 2 years Type, incidence, severity, seriousness, and relatedness of AEs. Type, incidence, and severity of laboratory abnormalities and significant changes from baseline.