Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03807765 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases
A Phase 1 study of Metastatic Breast Cancer and Brain Metastases, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03807765: Completed Phase 1 study of Metastatic Breast Cancer and Brain Metastases, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03807765 is a Phase 1 study of Metastatic Breast Cancer and Brain Metastases that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 14 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03807765, a Phase 1 study of Metastatic Breast Cancer and Brain Metastases, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is to find out if administration of stereotactic radiosurgery (SRS) given after Nivolumab will improve overall response rate/anti-tumor activity in patients with metastatic breast cancer with brain metastases.
Primary Outcome
Neurologic dose limiting toxicities will be defined as: Symptomatic radionecrosis, \>/= Grade 3 headache, \>/= Grade 3 memory impairment, New onset \>/= grade 3 seizures. 3 participants will be enrolled with an 8 week safety observation period. If no patients develop unacceptable neurologic toxicity attributable to SRS, the study will proceed. If 1 patient develops unacceptable neurologic toxicity among the first 3, an additional 3 patients will be enrolled to determine the rate of unacceptable
Conditions Studied
Interventions
- DRUG Nivolumab
- RADIATION Stereotactic Radiosurgery
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2025-03-18 |
| Phase | Phase 1 |
What the finished NCT03807765 record still lists
NCT03807765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03807765 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03807765 about?
NCT03807765 is a clinical study titled "Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases". This study is to find out if administration of stereotactic radiosurgery (SRS) given after Nivolumab will improve overall response rate/anti-tumor activity in patients with metastatic breast cancer with brain metastases.
What is the current status of trial NCT03807765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2019-01-30. Estimated completion is 2025-03-18.
What conditions does trial NCT03807765 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Brain Metastases.
What interventions are being tested in trial NCT03807765?
The interventions under investigation include: Nivolumab (DRUG), Stereotactic Radiosurgery (RADIATION).
Who is sponsoring clinical trial NCT03807765?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03807765 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic 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 NCT03807765's enrollment target sits among peer trials
14 133rd of 139 higher than 7 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
RECRUITING · Phase 1
-
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
RECRUITING · Phase 1
-
PRE-I-SPY Phase I/Ib Oncology Platform Program
RECRUITING · Phase 1
-
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
RECRUITING · Phase 1
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
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
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
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy