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NCT06966453 · ClinicalTrials.gov registry record · Phase 1
A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
A Phase 1 study of Breast Cancer and Breast Neoplasms, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06966453: Recruiting Phase 1 study of Breast Cancer and Breast Neoplasms, sponsored by Pfizer.
NCT06966453 is a Phase 1 study of Breast Cancer and Breast Neoplasms that is actively recruiting participants, run by Pfizer. The registered enrollment target is 100 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06966453, a Phase 1 study of Breast Cancer and Breast Neoplasms, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Disitamab vedotin
Study Locations (20)
California
- Los Angeles Cancer Network - Anaheim
- Los Angeles Cancer Network - Fountain Valley
- Los Angeles Hematology Oncology Medical Group - Glendale
- Los Angeles Cancer Network - Los Angeles
- Valkyrie Clinical Trials - Los Angeles
- Mission Community Hospital (Satellite Site) - Los Angeles
- Clinical and Translational Research Unit (CTRU) - Palo Alto
- Stanford Cancer Center - Palo Alto
- Stanford Women's Cancer Center - Palo Alto
- Stanford Health Care, Investigational Drug Service - Stanford
- Los Angeles Hematology Oncology Medical Group - Van Nuys
Colorado
- Rocky Mountain Cancer Centers, LLP - Aurora
- Rocky Mountain Cancer Centers, LLP - Boulder
- Rocky Mountain Cancer Centers, LLP - Centennial
- Rocky Mountain Cancer Centers, LLP - Colorado Springs
Alabama
- Southern Cancer Center, PC - Daphne
- Southern Cancer Center, PC - Foley
- Southern Cancer Center, PC - Mobile
Arizona
- Banner Gateway Medical Center - Gilbert
- Banner MD Anderson Cancer Center - Gilbert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-30 |
| Est. Completion | 2030-01-27 |
| Phase | Phase 1 |
What NCT06966453 shows while recruiting
NCT06966453 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Disitamab vedotin is the first listed.
NCT06966453 names 20 study sites across 4 states, led by California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT06966453 about?
NCT06966453 is a clinical study titled "A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer". 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 br...
What is the current status of trial NCT06966453?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-06-30. Estimated completion is 2030-01-27.
What conditions does trial NCT06966453 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms.
What interventions are being tested in trial NCT06966453?
The interventions under investigation include: Disitamab vedotin (DRUG).
Who is sponsoring clinical trial NCT06966453?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06966453 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06966453's enrollment target sits among peer trials
100 565th of 1224 higher than 630 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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