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Monoclonal Antibodies

Datopotamab Deruxtecan for Breast Cancer with Brain Metastases

Phase 2

Recruiting

Research Sponsored by Sarah Sammons, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of newly diagnosed brain metastases or brain metastases progressing after prior local and/or systemic therapy

Participants must have a baseline MRI of the brain performed with and without gadolinium contrast, and must have central nervous system metastases with at least one measurable brain metastasis ≥ 1.0 cm in size

Must not have

CNS complications for whom urgent neurosurgical intervention is indicated

Ongoing/persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test its safety & effectiveness in people with metastatic breast cancer that has spread to the brain.

Who is the study for?

This trial is for individuals with metastatic breast cancer that has spread to the brain. Specific details about who can join are not provided, but typically participants must meet certain health standards and may be required to have a particular type of breast cancer.

What is being tested?

The study is testing datopotamab deruxtecan, an antibody-drug conjugate, for its safety and effectiveness in treating patients whose breast cancer has metastasized to the brain.

What are the potential side effects?

While specific side effects are not listed here, antibody-drug conjugates like datopotamab deruxtecan often cause symptoms such as fatigue, nausea, hair loss, low blood cell counts increasing infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have new or worsening brain metastases.

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I have a brain tumor larger than 1.0 cm, confirmed by an MRI with contrast.

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My breast cancer is confirmed to not be HER2 positive.

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My cancer progressed after at least one hormone therapy in the metastatic stage.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of the day.

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My organs are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need urgent brain surgery due to complications.

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I still have side effects from cancer treatment that are not mild.

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I have a history of lung inflammation not caused by infection.

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I do not have uncontrolled seizures, CNS disorders, or severe psychiatric conditions.

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I have had cancer other than breast cancer.

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I am a man who is either surgically sterile or using contraception, and I do not donate sperm.

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I have a serious eye condition affecting my cornea.

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My cancer is causing severe organ problems.

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I am not currently breastfeeding or donating eggs.

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I am not receiving any other cancer treatments during this study.

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I do not have any unmanaged ongoing illnesses.

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I am not pregnant or have confirmed it with a test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) in RANO-BM Criteria

Secondary study objectives

Clinical Benefit Rate at 18 weeks (CBR18)

Clinical Benefit Rate at 24 weeks (CBR24)

Grade 3-5 Treatment-related Toxicity Rate

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C: HER2-Negative Metastatic Breast Cancer (any ER Expression) with Leptomeningeal MetastasesExperimental Treatment1 Intervention

* Baseline visit with CSF collection via lumbar puncture and assessments. * CT or MRI scans every 6 weeks for 24 weeks, then every 9 weeks. * Cycle 1 --Day 1 of 21 day cycle: Predetermined dose of Datopotamab Deruxtecan 1x daily. * Cycle 2 * Day 1 of 21 day cycle: Predetermined dose of Dato-DXd 1x daily. * Day 2 of 21 day cycle: CSF collection. * Cycle 3 Through End of Treatment: --Day 1 of 21 day cycle: Predetermined dose of Datopotamab Deruxtecan 1x daily. * End of Treatment: * Follow up every 6 months. * Optional CSF collection via lumbar puncture. * CT or MRI scans every 12 weeks.

Group II: Cohort B: Metastatic Triple-Negative Breast CancerExperimental Treatment1 Intervention

24 participants will be enrolled and will complete study procedures as outlined below: * Baseline visit with optional CSF collection via lumbar puncture and assessments. * CT or MRI scans every 6 weeks for 24 weeks, then every 9 weeks. * Cycle 1 Through End of Treatment: --Day 1 of 21 day cycle: Predetermined dose of Datopotamab Deruxtecan 1x daily. * End of Treatment: * Follow up every 6 months. * Optional CSF collection via lumbar puncture. * CT or MRI scans every 12 weeks.

Group III: Cohort A: Estrogen Receptor Positive HER2-Negative Metastatic Breast CancerExperimental Treatment1 Intervention

0 / 19Eligibility criteria met