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Monoclonal Antibodies

Cohort B: Metastatic Triple-Negative Breast Cancer for Breast Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) in RANO-BM Criteria

Secondary outcome measures

Clinical Benefit Rate at 18 weeks (CBR18)

Clinical Benefit Rate at 24 weeks (CBR24)

Grade 3-5 Treatment-related Toxicity Rate

+4 more

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor

392 Previous Clinical Trials

416,168 Total Patients Enrolled

25 Trials studying Breast Cancer

17,569 Patients Enrolled for Breast Cancer

Sarah Sammons, MDLead Sponsor

2 Previous Clinical Trials

49 Total Patients Enrolled

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

420,100 Total Patients Enrolled

27 Trials studying Breast Cancer

19,544 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being accepted for this research trial?

"Currently, according to clinicaltrials.gov this trial is not accepting new patient enrolment. Originally posted on May 1st 2024 and last updated in December of 2023, the 5416 other medical research projects are presently actively seeking volunteers for their respective studies."

Answered by AI

Has the FDA sanctioned Cohort A: Estrogen Receptor Positive HER2-Negative Metastatic Breast Cancer?

"Considering the current lack of clinical data supporting Cohort A: Estrogen Receptor Positive HER2-Negative Metastatic breast cancer's efficacy, our team at Power have rated its safety a 2 on their scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Sarah Sammons, MD 2023. "DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06176261.