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NCT03364348 · ClinicalTrials.gov registry record · Phase 1
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
A Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by George W. Sledge Jr..
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03364348: Completed Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by George W. Sledge Jr..
NCT03364348 is a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma that has completed, run by George W. Sledge Jr.. The registered enrollment target is 18 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03364348, a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, has completed, sponsored by George W. Sledge Jr..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to other places in the body. Monoclonal antibodies, such as utomilumab, trastuzumab emtansine, and trastuzumab may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Dose-limiting toxicities (DLTs) within the first 2 cycles (6 weeks) of treatment were assessed. DLTs are treatment-related adverse events defined as: * Neutropenia Grade (Gr) 4 \>7 days * Febrile neutropenia, defined as absolute neutrophil count \<1000/mm3 with a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of ≥38 degrees C (100.4 degrees F) for \>1 hour * Neutropenic infection ≥Gr 3 * Thrombocytopenia ≥Gr 4, or with bleeding Gr 3 * Non-laboratory toxicities
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Utomilumab
- DRUG Ado-Trastuzumab Emtansine
Study Locations (1)
California
- Stanford University, School of Medicine - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-10-30 |
| Est. Completion | 2022-02-14 |
| Phase | Phase 1 |
What the finished NCT03364348 record still lists
NCT03364348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (73% lower).
The record links to 7 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.
NCT03364348 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03364348 about?
NCT03364348 is a clinical study titled "4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer". This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to other places in the body. Monoclonal antibodies, such as utomilumab, tras...
What is the current status of trial NCT03364348?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-10-30. Estimated completion is 2022-02-14.
What conditions does trial NCT03364348 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer.
What interventions are being tested in trial NCT03364348?
The interventions under investigation include: Trastuzumab (DRUG), Utomilumab (DRUG), Ado-Trastuzumab Emtansine (DRUG).
Who is sponsoring clinical trial NCT03364348?
This trial is sponsored by George W. Sledge Jr., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03364348 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV 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 NCT03364348's enrollment target sits among peer trials
18 26th of 30 higher than 4 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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