Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03523572 · ClinicalTrials.gov registry record · Phase 1
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT03523572: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT03523572 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03523572, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
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.
Primary Outcome
A Dose-Limiting Toxicity (DLT) is defined as any Treatment Emergent Adverse Event not attributable to disease or disease-related processes that occurs during the DLT evaluation period (2 complete cycles during Part 1) and is Grade 3 or above according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Each cycle is 21 days. Low dose was set at 3.2 mg/kg and high dose was set at 5.4 mg/kg.
Interventions
- DRUG Nivolumab
- DRUG Trastuzumab deruxtecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2018-08-02 |
| Est. Completion | 2023-09-12 |
| Phase | Phase 1 |
What the finished NCT03523572 record still lists
NCT03523572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03523572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03523572 about?
NCT03523572 is a clinical study titled "Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer". 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....
What is the current status of trial NCT03523572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2018-08-02. Estimated completion is 2023-09-12.
What interventions are being tested in trial NCT03523572?
The interventions under investigation include: Nivolumab (DRUG), Trastuzumab deruxtecan (DRUG).
Who is sponsoring clinical trial NCT03523572?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03523572's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01639508 · 86 participants · Phase 2
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity
- NCT03519269 · 86 participants · NA
Navio Robotic Versus Conventional Total Knee Arthroplasty
- NCT04132999 · 86 participants · NA
PAP for Children With DS and OSAS
- NCT04545957 · 86 participants · NA
Jump: MR Simulation For Radiation Therapy Master Protocol
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI