Clinical trial · Interventional
ANG1005 in Leptomeningeal Disease From Breast Cancer
A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)
NCT03613181CI-TRIAL-00065903ANGLeDunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Leptomeningeal Carcinomatosis | — | UNRESOLVED | — |
| Leptomeningeal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ANG1005 | Drug | — | UNRESOLVED |
| Physician's Best Choice | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ANG1005
- description
- ANG1005 Investigational Drug
- interventionNames
- Drug: ANG1005
- type
- ACTIVE_COMPARATOR
- label
- Physician's Best Choice
- description
- One of the protocol specified Physician's Best Choice therapies, assigned by the Investigator prior to randomization: capecitabine or eribulin or high-dose intravenous (IV) methotrexate.
- interventionNames
- Drug: Physician's Best Choice
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From the date of randomization until death due to any cause, assessed for up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years old 2. HER2-negative breast cancer 3. At least 2 months of expected survival 4. Newly diagnosed leptomeningeal carcinomatosis 5. Documented history of brain metastasis that has been previously treated with radiation therapy 6. Neurologically stable 7. Eastern Cooperative Oncology Group performance status grade ≤2 8. Adequate laboratory test results prior to first dose 9. Patients who are fertile must agree to remain abstinent or use reliable method of birth control Exclusion Criteria: 1. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt 2. Prior treatment with ANG1005 3. Patients who have not had radiotherapy for their brain metastases 4. Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure 5. Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal disease 6. Pregnancy or lactation and patients planning to be pregnant during the study 7. Peripheral neuropathy \> Grade 2 8. Evidence of severe or uncontrolled diseases 9. Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV 10. History of interstitial lung disease 11. Severe conduction disturbance 12. Central nervous system disease requiring immediate neurosurgical intervention 13. Known allergy to paclitaxel or any of its components 14. Contra-indication for contrast-enhanced MRI
References
Publications (0)
Data not yet available
No reference posted for this study.