UnknownPhase 3

ANG1005 in Leptomeningeal Disease From Breast Cancer

150 participantsStarted 2023-12

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ≥ 18 years old
. HER2-negative breast cancer
. At least 2 months of expected survival
. Newly diagnosed leptomeningeal carcinomatosis
. Documented history of brain metastasis that has been previously treated with radiation therapy
. Neurologically stable
. Eastern Cooperative Oncology Group performance status grade ≤2
. Adequate laboratory test results prior to first dose

Exclusion criteria

. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt
. Prior treatment with ANG1005
. Patients who have not had radiotherapy for their brain metastases
. Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

Timeframe: From the date of randomization until death due to any cause, assessed for up to 2 years.

Trial details

NCT IDNCT03613181

SponsorAngiochem Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

John Huss

1-514-788-7800 jhuss@angiochem.com

View on ClinicalTrials.gov More Leptomeningeal Carcinomatosis trials