Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03579472 · ClinicalTrials.gov registry record · Phase 1
M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT03579472: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03579472 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03579472, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This phase Ib trial studies the best dose and side effects of eribulin mesylate when given together with M7824)in treating patients with triple negative breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as M7824, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving eribulin mesylate and M7824 may work better at treating triple negative breast cancer.
Primary Outcome
Will be defined as highest dose with dose limiting toxicity (DLT) rate =\< 30%. The number of patients on each dose as well as DLTs will be summarized. Bayesian optimal interval (BOIN) design will be employed to identify the RP2D of eribulin with M7824.
Interventions
- DRUG Bintrafusp Alfa
- DRUG Eribulin Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2022-09-21 |
| Phase | Phase 1 |
Why NCT03579472 stopped before completion
NCT03579472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Bintrafusp Alfa is the first listed.
NCT03579472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03579472 about?
NCT03579472 is a clinical study titled "M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer". This phase Ib trial studies the best dose and side effects of eribulin mesylate when given together with M7824)in treating patients with triple negative breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop th...
What is the current status of trial NCT03579472?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2018-05-30. Estimated completion is 2022-09-21.
What interventions are being tested in trial NCT03579472?
The interventions under investigation include: Bintrafusp Alfa (DRUG), Eribulin Mesylate (DRUG).
Who is sponsoring clinical trial NCT03579472?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03579472's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
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