Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
Public ClinicalTrials.gov record NCT03523572. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study of trastuzumab deruxtecan for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: * Part 1 is to identify the recommended dose to use for treatment. * Part 2 is to find out how well the combination works, and how safe and tolerable it is.
Study identification
- NCT ID
- NCT03523572
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2, 2018 (Actual)
- Primary completion
- Jul 22, 2021 (Actual)
- Completion
- Sep 12, 2023 (Actual)
- Last update posted
- Jan 27, 2025
2018 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA - Medical Center | Santa Monica | California | 90404 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Levine Cancer Institute Carolinas Healthcare System | Charlotte | North Carolina | 28204 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Tennessee Oncology - Sara Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| University of Washington Medical Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03523572, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2025 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03523572 live on ClinicalTrials.gov.